RESUMEN
INTRODUCTION: Most solid organ transplants originate from donors meeting criteria for death by neurological criteria (DNC). Within the organ donor, physiological responses to brain death increase the risk of ischaemia reperfusion injury and delayed graft function. Donor preconditioning with calcineurin inhibition may reduce this risk. METHODS AND ANALYSIS: We designed a multicentre placebo-controlled pilot randomised trial involving nine organ donation hospitals and all 28 transplant programmes in the Canadian provinces of Ontario and Québec. We planned to enrol 90 DNC donors and their approximately 324 organ recipients, totalling 414 participants. Donors receive an intravenous infusion of either tacrolimus 0.02 mg/kg over 4 hours prior to organ retrieval, or a matching placebo, while monitored in an intensive care unit for any haemodynamic changes during the infusion. Among all study organ recipients, we record measures of graft function for the first 7 days in hospital and we will record graft survival after 1 year. We examine the feasibility of this trial with respect to the proportion of all eligible donors enrolled and the proportion of all eligible transplant recipients consenting to receive a CINERGY organ transplant and to allow the use of their health data for study purposes. We will report these feasibility outcomes as proportions with 95% CIs. We also record any barriers encountered in the launch and in the implementation of this trial with detailed source documentation. ETHICS AND DISSEMINATION: We will disseminate trial results through publications and presentations at participating sites and conferences. This study has been approved by Health Canada (HC6-24-c241083) and by the Research Ethics Boards of all participating sites and in Québec (MP-31-2020-3348) and Clinical Trials Ontario (Project #3309). TRIAL REGISTRATION NUMBER: NCT05148715.
Asunto(s)
Inhibidores de la Calcineurina , Funcionamiento Retardado del Injerto , Trasplante de Riñón , Donantes de Tejidos , Adulto , Femenino , Humanos , Masculino , Muerte Encefálica , Inhibidores de la Calcineurina/administración & dosificación , Inhibidores de la Calcineurina/uso terapéutico , Funcionamiento Retardado del Injerto/prevención & control , Supervivencia de Injerto/efectos de los fármacos , Inmunosupresores/administración & dosificación , Inmunosupresores/uso terapéutico , Estudios Multicéntricos como Asunto , Ontario , Proyectos Piloto , Quebec , Ensayos Clínicos Controlados Aleatorios como Asunto , Tacrolimus/uso terapéutico , Tacrolimus/administración & dosificaciónRESUMEN
Background: Organ and Tissue Donation Coordinators (OTDCs) are key to the success of deceased organ donation processes. However, reduced resilience can leave them susceptible to the incidence of work-related issues and decrease the quality of the care provided. Therefore, this study aimed to examine the extent of resilience and influencing aspects among OTDCs in Canada. Methods: Mixed-method (QUAN-qual) explanatory sequential design. Quantitative data was collected using an online cross-sectional survey approach with demographic data and the validated scales and analyzed using descriptive and inferential statistics. Qualitative data was collected using a descriptive approach with a semi-structured interview guide and analyzed using content analysis. Results: One hundred twenty participants responded to the survey, and 39 participants were interviewed. Most participants from the survey were female (82%), registered nurses (97%) and on average 42 years old. The quantitative data revealed that OTDCs had a high level of perceived compassion satisfaction (ProQOL-CS = 36.3) but a resilience score (CD-RISC = 28.5) lower than other groups of healthcare professionals. OTDCs with over a year of experience in the role were more likely to have higher levels of resilience. The qualitative data identified that participants saw resilience as crucial for their work-related well-being. Although coping strategies were identified as a key factor that enhance resilience, many OTDCs reported difficulty in developing healthy coping strategies, and that the use of unhealthy mechanisms (e.g., alcohol and smoking) can result in negative physical consequences (e.g., weight gain) and reduced resilience levels. Conclusion: Participants reported using a series of coping and protective strategies to help build resilience, but also difficulty in developing healthy mechanisms. The lack of healthy coping strategies were seen as contributing to negative work-related issues (e.g., burnout). Our findings are being used to develop tailored interventions to improve resilience and healthy coping strategies among organ donor coordinators in Canada.
Asunto(s)
Pruebas Psicológicas , Resiliencia Psicológica , Obtención de Tejidos y Órganos , Humanos , Femenino , Adulto , Masculino , Estudios Transversales , CanadáRESUMEN
OBJECTIVE: The objective of this review was to collate and summarize the current literature on what is known about organ donation following medical assistance in dying (MAiD). Additionally, for this first part of a 2-part scoping review, the focus is on legal and ethical considerations regarding organ donation following MAiD. INTRODUCTION: Organ donation following MAiD is a relatively new procedure that has sparked much debate and discussion. A comprehensive investigation into the legal and ethical aspects related to organ donation following MAiD is needed to inform the development of safe and ethical practices. INCLUSION CRITERIA: In this review, we included documents that investigated legal and/or ethical issues related to individuals who underwent organ donation following MAiD in any setting (eg, hospital or home) worldwide. We considered quantitative and qualitative studies, text and opinion papers, gray literature, and unpublished material provided by stakeholders. METHODS: This scoping review followed JBI methodology. Published studies were retrieved from databases, including MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), Web of Science Core Collection, and Academic Search Complete (EBSCOhost). Gray and unpublished literature included reports from organ donation organizations in Canada, The Netherlands, and Belgium. Two independent reviewers screened all reports (both by title and abstract and by full text) against the inclusion criteria, extracted data, and completed a content analysis. Disagreements between the 2 reviewers were resolved through discussions among the reviewers and the lead reviewer. RESULTS: We included 121 documents for parts I and II of our scoping review, 89 of which are included in part I. The majority of the 89 documents were discussion papers published in English and in Canada from 2019 to 2021. In the content analysis, we identified 4 major categories regarding ethical and legal aspects of organ donation following MAiD: i) legal definitions, legislation, and guidelines; ii) ethics, dilemmas, and consensus; iii) consent and objection; and iv) public perceptions. We identified the main legislation regulating the practices of organ donation following MAiD in countries where both procedures are permitted, the many ethical debates surrounding this topic (eg, eligibility criteria for organ donation and MAiD, disclosure of donors' and recipients' information, directed organ donation, death determination in organ donation following MAiD, ethical safeguards for organ donation following MAiD), as well as the public perceptions of this process. CONCLUSIONS: Organ donation following MAiD has raised many legal and ethical concerns regarding establishing safeguards to protect patients and families. Despite the ongoing debates around the risks and benefits of this combined procedure, when patients who request MAiD want to donate their organs, this option can help fulfill their last wishes and diminish their suffering, which should be the main reasons to offer organ donation following MAiD.
Asunto(s)
Suicidio Asistido , Obtención de Tejidos y Órganos , Humanos , Donantes de Tejidos , Asistencia Médica , CanadáRESUMEN
OBJECTIVES: Evaluate literature on the dying process in children after withdrawal of life sustaining measures (WLSM) in the PICU. We focused on the physiology of dying, prediction of time to death, impact of time to death, and uncertainty of the dying process on families, healthcare workers, and organ donation. DATA SOURCES: MEDLINE, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, CINAHL, and Web of Science. STUDY SELECTION: We included studies that discussed the dying process after WLSM in the PICU, with no date or study type restrictions. We excluded studies focused exclusively on adult or neonatal populations, children outside the PICU, or on organ donation or adult/pediatric studies where pediatric data could not be isolated. DATA EXTRACTION: Inductive qualitative content analysis was performed. DATA SYNTHESIS: Six thousand two hundred twenty-five studies were screened and 24 included. Results were grouped into four categories: dying process, perspectives of healthcare professionals and family, WLSM and organ donation, and recommendations for future research. Few tools exist to predict time to death after WLSM in children. Most deaths after WLSM occur within 1 hour and during this process, healthcare providers must offer support to families regarding logistics, medications, and expectations. Providers describe the unpredictability of the dying process as emotionally challenging and stressful for family members and staff; however, no reports of families discussing the impact of time to death prediction were found. The unpredictability of death after WLSM makes families less likely to pursue donation. Future research priorities include developing death prediction tools of tools, provider and parental decision-making, and interventions to improve end-of-life care. CONCLUSIONS: The dying process in children is poorly understood and understudied. This knowledge gap leaves families in a vulnerable position and the clinical team without the necessary tools to support patients, families, or themselves. Improving time to death prediction after WLSM may improve care provision and enable identification of potential organ donors.
Asunto(s)
Cuidado Terminal , Obtención de Tejidos y Órganos , Recién Nacido , Adulto , Niño , Humanos , Familia/psicología , Cuidados Paliativos/psicología , Donantes de Tejidos , MuerteAsunto(s)
Reanimación Cardiopulmonar , Retorno de la Circulación Espontánea , Humanos , Polonia , SíndromeRESUMEN
OBJECTIVE: The objective of this review was to collate and summarize the current literature on what is known about organ donation following medical assistance in dying (MAiD). For this second part of a 2-part scoping review, the focus is on the existing procedures and processes for organ donation following MAiD. INTRODUCTION: Organ donation following MAiD is a novel and contentious issue worldwide. To give direction for future research and initiatives, a comprehensive understanding of the available evidence of existing procedures and processes for organ donation following MAiD is needed. INCLUSION CRITERIA: For this review, the population of interest included all individuals who underwent organ donation following MAiD; the concept was defined as procedures and processes involved in organ donation after MAiD; and the context was reports of organ donation following MAiD at home or in any health care setting worldwide. We considered quantitative and qualitative studies, text and opinion papers, gray literature, and unpublished material provided by stakeholders. METHODS: This scoping review was conducted in line with JBI methodology. Published studies were retrieved from MEDLINE (Ovid), Embase (Ovid), CINAHL (EBSCOhost), PsycINFO (Ovid), Web of Science Core Collection, and Academic Search Complete (EBSCOhost). Gray and unpublished literature included reports from websites and organ donation organizations in Canada, Belgium, and The Netherlands. Two independent reviewers screened all reports (both title and abstract, and full text) against the predetermined inclusion criteria, extracted data, and completed a content analysis. Any disagreements between the 2 reviewers were resolved through discussion or with another reviewer. RESULTS: We included 121 documents across parts I and II, and we report on 107 documents in this second part. The majority of the 107 documents were discussion papers, published in English, and in Canada from 2019 to 2021. In the content analysis, we identified 5 major categories regarding existing procedures and processes of organ donation following MAiD: i) clinical pathways for organ donation following MAiD; ii) organ donation following MAiD and the donor; iii) clinical practice tools for organ donation following MAiD; iv) education and support for health care providers involved in organ donation following MAiD; and v) health care providers' roles and perceptions during organ donation following MAiD. CONCLUSIONS: Findings from this review can be used to provide support and guidance for improvements in procedures and processes, as well as a rich resource for countries currently planning to establish programs for organ donation after MAiD.
Asunto(s)
Suicidio Asistido , Obtención de Tejidos y Órganos , Humanos , Donantes de Tejidos , Canadá , Asistencia MédicaRESUMEN
OBJECTIVE: To investigate whether observable differences exist between patterns of withdrawal of life-sustaining measures (WLSM) for patients eligible for donation after circulatory death (DCD) in whom donation was attempted compared with those patients in whom no donation attempts were made. SETTING: Adult intensive care units from 20 centres in Canada, the Czech Republic and the Netherlands. DESIGN: Secondary analysis of quantitative data collected as part of a large, prospective, cohort study (the Death Prediction and Physiology after Removal of Therapy study). PARTICIPANTS: Patients ≥18 years of age who died after a controlled WLSM in an intensive care unit. Patients were classified as not DCD eligible, DCD eligible with DCD attempted or DCD eligible but DCD was not attempted. PRIMARY AND SECONDARY OUTCOME MEASURES: The process of WLSM (timing and type and, if applicable, dosages of measures withdrawn, dosages of analgesics/sedatives) was compared between groups. RESULTS: Of the 635 patients analysed, 85% had either cardiovascular support stopped or were extubated immediately on WLSM. Of the DCD eligible patients, more were immediately extubated at the initiation of WLSM when DCD was attempted compared with when DCD was not attempted (95% vs 61%, p<0.0001). Initiation of WLSM with the immediate cessation of cardiovascular measures or early extubation was associated with earlier time to death, even after adjusting for confounders (OR 2.94, 95% CI 1.39 to 6.23, at 30 min). Other than in a few patients who received propofol, analgesic and sedative dosing after WLSM between DCD attempted and DCD eligible but not attempted patients was not significantly different. All patients died. CONCLUSIONS: Patients in whom DCD is attempted may receive a different process of WLSM. This highlights the need for a standardised and transparent process for end-of-life care across the spectrum of critically ill patients and potential organ donors.
Asunto(s)
Unidades de Cuidados Intensivos , Pacientes , Adulto , Humanos , Estudios de Cohortes , Estudios Prospectivos , Extubación Traqueal , Hipnóticos y SedantesRESUMEN
PURPOSE: To describe and review the experience of two pediatric intensive care units (PICUs) in Ontario, Canada, adapting and providing care to critically ill adults during the COVID-19 pandemic. CLINICAL FEATURES: At a time of extreme pressure to adult intensive care unit (ICU) capacity, two PICUs provided care to critically ill adults with COVID-19 pneumonia. Substantial yet rapid planning was required to facilitate safe delivery of critical care to adult patients while maintaining PICU services, including thoughtful development of care pathways and patient selection. To prepare clinical staff, several communication strategies, knowledge translation, skill consolidation, and system-adaptation mechanisms were developed. There was iterative adaptation of operational processes, including staffing models, specialist consultation, and the pharmacy. Care provided by the interprofessional teams was reoriented as appropriate to the needs of critically ill adults in close collaboration with adult ICU teams. Forty-one adults were admitted to the two PICUs over a 12-week period. In total, 36 patients (88%) received invasive ventilation, eight patients (20%) were supported with venovenous extracorporeal membrane oxygenation, and six patients (15%) received continuous renal replacement therapy. Four died in the PICU during this period. Feedback from staff included anxiety around reorienting practice to the care of critically ill adults, physical exhaustion, and psychological distress. Importantly, staff also reported a renewed sense of purpose with participation in the program. CONCLUSION: Though challenging, the experience has provided opportunity to enhance collaboration with partner institutions and improve the care of older children and adolescents in the PICU.
RéSUMé: OBJECTIF: Nous avions pour objectif de décrire et examiner l'expérience de deux unités de soins intensifs pédiatriques (USIP) en Ontario, au Canada, qui se sont adaptées et ont fourni des soins aux adultes gravement malades pendant la pandémie de COVID-19. CARACTéRISTIQUES CLINIQUES: À l'époque où la capacité des unités de soins intensifs (USI) pour adultes était extrêmement sollicitée, deux USIP ont prodigué des soins à des adultes gravement malades souffrant de pneumonie liée à la COVID-19. Une planification substantielle mais rapide a été nécessaire pour faciliter la prestation sécuritaire de soins intensifs à une patientèle adulte tout en maintenant les services de l'USIP, y compris l'élaboration réfléchie des trajectoires de soins et la sélection de la patientèle. Pour préparer le personnel clinique, plusieurs stratégies de communication, d'application des connaissances, de consolidation des compétences et de mécanismes d'adaptation du système ont été élaborées. Il y a eu une adaptation progressive des processus opérationnels, y compris des modèles de dotation, des consultations de spécialistes et de la pharmacie. Les soins fournis par les équipes interprofessionnelles ont été réorientés en fonction des besoins des adultes gravement malades en étroite collaboration avec les équipes adultes de soins intensifs. Quarante et une personnes adultes ont été admises dans les deux unités de soins intensifs pédiatriques sur une période de 12 semaines. Au total, 36 adultes (88 %) ont bénéficié d'une ventilation invasive, huit personnes (20 %) ont reçu une oxygénation par membrane extracorporelle veino-veineuse, et six (15 %) ont reçu un traitement substitutif de l'insuffisance rénale en continu. Quatre personnes sont décédées à l'USIP au cours de cette période. Les commentaires du personnel comprenaient de l'anxiété liée à la réorientation de leur pratique vers des soins à des adultes gravement malades, l'épuisement physique et la détresse psychologique. Fait important, le personnel a également signalé un regain de motivation lié à la participation de leur USIP à ce programme. CONCLUSION: Bien que difficile, l'expérience a permis d'améliorer la collaboration avec les établissements partenaires et d'améliorer les soins aux enfants plus âgé·es et aux adolescent·es de l'USIP.
Asunto(s)
COVID-19 , Niño , Adolescente , Humanos , Adulto , Ontario , Enfermedad Crítica/terapia , Pandemias , Unidades de Cuidado Intensivo Pediátrico , Unidades de Cuidados IntensivosRESUMEN
Background: Preconditioning deceased organ donors with calcineurin inhibitors (CNIs) may reduce ischemia-reperfusion injury to improve transplant outcomes. Methods: We searched MEDLINE, EMBASE, Cochrane Library, and conference proceedings for animal models of organ donation and transplantation, comparing donor treatment with CNIs with either placebo or no intervention, and evaluating outcomes for organ transplantation. Reviewers independently screened and selected studies, abstracted data, and assessed the risk of bias and clinical relevance of included studies. Where possible, we pooled results using meta-analysis; otherwise, we summarized findings descriptively. Results: Eighteen studies used various animals and a range of CNI agents and doses and evaluated their effects on a variety of transplant outcomes. The risk of bias and clinical applicability were poorly reported. Pooled analyses suggested benefit of CNI treatment on early graft function in renal transplants (3 studies; serum creatinine: ratio of means [RoM] 0.54; 95% confidence interval [CI], 0.34-0.86) but not for liver transplants (2 studies; serum alanine transaminase: RoM 0.61; 95% CI, 0.30-1.26; and serum aspartate aminotransferase: RoM 0.58; 95% CI, 0.26-1.31). We found no reduction in graft loss at 7 d (2 studies; risk ratio 0.54; 95% CI, 0.08-3.42). CNI treatment was associated with reduced transplant recipient levels of interleukin-6 (4 studies; RoM 0.36; 95% CI, 0.19-0.70), tumor necrosis factor-alpha (5 studies; RoM 0.36; 95% CI, 0.12-1.03), and cellular apoptosis (4 studies; RoM 0.30; 95% CI, 0.19-0.47). Conclusions: Although this compendium of animal experiments suggests that donor preconditioning with CNIs may improve early kidney graft function, the limited ability to reproduce a true clinical environment in animal experiments and to assess for risk of bias in these experiments is a serious weakness that precludes current clinical application.
RESUMEN
PURPOSE: There is lack of consensus regarding the minimum arterial pulse pressure required for confirming permanent cessation of circulation for death determination by circulatory criteria in organ donors. We assessed direct and indirect evidence supporting whether one should use an arterial pulse pressure of 0 mm Hg vs more than 0 (5, 10, 20, 40) mm Hg to confirm permanent cessation of circulation. SOURCE: We conducted this systematic review as part of a larger project to develop a clinical practice guideline for death determination by circulatory or neurologic criteria. We systematically searched Ovid MEDLINE, Ovid Embase, Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library, and Web of Science for articles published from inception until August 2021. We included all types of peer-reviewed original research publications related to arterial pulse pressure as monitored by an indwelling arterial pressure transducer around circulatory arrest or determination of death with either direct context-specific (organ donation) or indirect (outside of organ donation context) data. PRINCIPAL FINDINGS: A total of 3,289 abstracts were identified and screened for eligibility. Fourteen studies were included; three from personal libraries. Five studies were of sufficient quality for inclusion in the evidence profile for the clinical practice guideline. One study measured cessation of cortical scalp electroencephalogram (EEG) activity after withdrawal of life-sustaining measures and showed that EEG activity fell below 2 µV when the pulse pressure reached 8 mm Hg. This indirect evidence suggests there is a possibility of persistent cerebral activity at arterial pulse pressures > 5 mm Hg. CONCLUSION: Indirect evidence suggests that clinicians may incorrectly diagnose death by circulatory criteria if they apply any arterial pulse pressure threshold of greater than 5 mm Hg. Moreover, there is insufficient evidence to determine that any pulse pressure threshold greater than 0 and less than 5 can safely determine circulatory death. STUDY REGISTRATION: PROSPERO (CRD42021275763); first submitted 28 August 2021.
RéSUMé: OBJECTIF: Il n'y a pas de consensus concernant la pression artérielle minimale requise pour confirmer l'arrêt permanent de la circulation pour la détermination du décès selon des critères circulatoires chez les donneurs d'organes. Nous avons évalué les données probantes directes et indirectes soutenant l'utilisation d'une pression pulsée artérielle de 0 mmHg vs plus de 0 (5, 10, 20, 40) mm Hg pour confirmer l'arrêt définitif de la circulation. SOURCES: Nous avons réalisé cette revue systématique dans le cadre d'un projet plus vaste visant à élaborer des lignes directrices de pratique clinique pour la détermination du décès selon des critères circulatoires ou neurologiques. Nous avons mené des recherches systématiques dans Ovid MEDLINE, Ovid Embase, le registre Cochrane des études contrôlées (CENTRAL) via la Cochrane Library et Web of Science pour trouver des articles publiés depuis leur création jusqu'en août 2021. Nous avons inclus tous les types de publications de recherches originales évaluées par des pairs liées à la pression pulsée artérielle telle que surveillée par un transducteur de pression artérielle à demeure entourant un arrêt circulatoire ou de une détermination de décès avec des données directes spécifiques au contexte (don d'organes) ou indirectes (en dehors d'un contexte du don d'organes). CONSTATATIONS PRINCIPALES: Au total, 3289 résumés ont été identifiés et examinés pour déterminer leur admissibilité. Quatorze études ont été incluses, trois provenant de bibliothèques personnelles. Cinq études étaient de qualité suffisante pour être incluses dans le profil de données probantes des Lignes directrices de pratique clinique. Une étude a mesuré l'arrêt de l'activité de l'électroencéphalogramme (EEG) au niveau du scalp cortical après l'interruption des thérapies de maintien des fonctions vitales et a montré que l'activité EEG tombait en dessous de 2 µV lorsque la pression pulsée atteignait 8 mm Hg. Ces données probantes indirectes suggèrent qu'il existe une possibilité d'activité cérébrale persistante à des pressions pulsées artérielles > 5 mm Hg. CONCLUSION: Des données probantes indirectes suggèrent que les cliniciens pourraient diagnostiquer à tort un décès selon des critères circulatoires s'ils appliquent un seuil de pression pulsée artérielle supérieur à 5 mm Hg. De plus, il n'y a pas suffisamment de données probantes pour déterminer que tout seuil de pression pulsée supérieur à 0 et inférieur à 5 peut permettre de déterminer en toute sécurité un décès cardiocirculatoire. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42021275763); soumis pour la première fois le 28 août 2021.
Asunto(s)
Paro Cardíaco , Obtención de Tejidos y Órganos , Humanos , Presión Sanguínea , Encéfalo , Donantes de Tejidos , MuerteRESUMEN
PURPOSE: To synthesize the available evidence comparing noninvasive methods of measuring the cessation of circulation in patients who are potential organ donors undergoing death determination by circulatory criteria (DCC) with the current accepted standard of invasive arterial blood pressure (IAP) monitoring. SOURCE: We searched (from inception until 27 April 2021) MEDLINE, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials. We screened citations and manuscripts independently and in duplicate for eligible studies that compared noninvasive methodologies assessing circulation in patients who were monitored around a period of cessation of circulation. We performed risk of bias assessment, data abstraction, and quality assessment using Grading of Recommendations, Assessment, Development, and Evaluation in duplicate and independently. We presented findings narratively. PRINCIPAL FINDINGS: We included 21 eligible studies (N = 1,177 patients). Meta-analysis was not possible because of study heterogeneity. We identified low quality evidence from four indirect studies (n = 89) showing pulse palpation is less sensitive and specific than IAP (reported sensitivity range, 0.76-0.90; specificity, 0.41-0.79). Isoelectric electrocardiogram (ECG) had excellent specificity for death (two studies; 0% [0/510]), but likely increases the average time to death determination (moderate quality evidence). We are uncertain whether point-of-care ultrasound (POCUS) pulse check, cerebral near-infrared spectroscopy (NIRS), or POCUS cardiac motion assessment are accurate tests for the determination of circulatory cessation (very low-quality evidence). CONCLUSION: There is insufficient evidence that ECG, POCUS pulse check, cerebral NIRS, or POCUS cardiac motion assessment are superior or equivalent to IAP for DCC in the setting of organ donation. Isoelectric ECG is specific but can increase the time needed to determine death. Point-of-care ultrasound techniques are emerging therapies with promising initial data but are limited by indirectness and imprecision. STUDY REGISTRATION: PROSPERO (CRD42021258936); first submitted 16 June 2021.
RéSUMé: OBJECTIF: Synthétiser les données probantes disponibles comparant les méthodes non invasives de mesure de l'arrêt de la circulation chez les patients qui sont des donneurs d'organes potentiels soumis à une détermination du décès selon des critères circulatoires (DCC) avec la norme actuellement acceptée de surveillance invasive de la tension artérielle (TA). SOURCES: Nous avons mené des recherches dans les bases de données MEDLINE, EMBASE, Web of Science et le registre Cochrane des essais contrôlés de leur création jusqu'au 27 avril 2021. Nous avons examiné les citations et les manuscrits de manière indépendante et en double pour en tirer les études éligibles qui comparaient des méthodologies non invasives d'évaluation de la circulation chez les patients qui étaient sous surveillance avant, pendant et après une période d'arrêt de la circulation. Nous avons réalisé l'évaluation du risque de biais, l'extraction des données et l'évaluation de la qualité en nous fondant sur la méthodologie GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) en double et de manière indépendante. Nous présentons les résultats de façon narrative. CONSTATATIONS PRINCIPALES: Nous avons inclus 21 études éligibles (N = 1177 patients). Une méta-analyse n'a pas été possible en raison de l'hétérogénéité des études. Nous avons identifié des données de faible qualité issues de quatre études indirectes (n = 89) montrant que la palpation du pouls est moins sensible et spécifique que la mesure invasive de la TA (plage de sensibilité rapportée, 0,76-0,90; spécificité, 0,41-0,79). L'électrocardiogramme (ECG) isoélectrique avait une excellente spécificité pour le décès (deux études; 0 % [0/510]), mais augmente probablement le délai moyen avant la détermination du décès (données probantes de qualité modérée). Nous ne savons pas si la vérification du pouls par échographie ciblée (POCUS), la spectroscopie proche infrarouge (SPIR) cérébrale ou l'évaluation ciblée (POCUS) des mouvements cardiaques sont des examens précis pour la détermination de l'arrêt circulatoire (données probantes de très faible qualité). CONCLUSION: Il n'y a pas suffisamment de données probantes pour affirmer que l'ECG, la vérification ciblée du pouls, la SPIR cérébrale ou l'évaluation ciblée des mouvements cardiaques sont supérieurs ou équivalents à la mesure invasive de la TA pour un DCC dans le cadre du don d'organes. L'ECG isoélectrique est spécifique, mais peut augmenter le délai nécessaire avant de déterminer le décès. Les techniques d'échographie ciblée sont des thérapies émergentes avec des données initiales prometteuses, mais elles sont limitées par leur caractère indirect et l'imprécision de l'examen. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42021258936); soumis pour la première fois le 16 juin 2021.
Asunto(s)
Pruebas Diagnósticas de Rutina , Humanos , UltrasonografíaRESUMEN
In April 2019, the province of Nova Scotia became the first jurisdiction in North America to pass legislation that incorporated deemed consent for deceased organ donation. The reform included many other important updates, including the hierarchy for consent, enabled donor and recipient contact, and mandatory referral of potential deceased donors. Additionally, system reforms were implemented to improve the deceased donation system in Nova Scotia. A collection of national colleagues identified the magnitude of the opportunity to develop a comprehensive strategy to measure and evaluate the impact of the legislative and system reforms. This article describes the successful development of a consortium from both national and provincial jurisdictions that included experts from a variety of backgrounds and clinical and administrative disciplines. In describing the creation of this group, we hope to offer our case example as a model for the evaluation of other health system reforms from a multidisciplinary perspective.
Asunto(s)
Obtención de Tejidos y Órganos , Humanos , Donantes de Tejidos , Nueva EscociaRESUMEN
This report provides recommendations from the Research and Innovation domain as part of the International Donation and Transplantation Legislative and Policy Forum (hereafter the Forum) to provide expert guidance on the structure of an ideal organ and tissue donation and transplantation system. The recommendations focus on deceased donation research and are intended for clinicians, investigators, decision-makers, and patient, family, and donor (PFD) partners involved in the field. Methods: We identified topics impacting donation research through consensus using nominal group technique. Members performed narrative reviews and synthesized current knowledge on each topic, which included academic articles, policy documents, and gray literature. Using the nominal group technique, committee members discussed significant findings, which provided evidence for our recommendations. The Forum's scientific committee then vetted recommendations. Results: We developed 16 recommendations in 3 key areas to provide stakeholders guidance in developing a robust deceased donor research framework. These include PFD and public involvement in research; donor, surrogate, and recipient consent within a research ethics framework; and data management. We highlight the importance of PFD and public partner involvement in research, we define the minimum ethical requirements for the protection of donors and recipients of both target and nontarget organ recipients, and we recommend the creation of a centrally administered donor research oversight committee, a single specialist institutional review board, and a research oversight body to facilitate coordination and ethical oversight of organ donor intervention research. Conclusions: Our recommendations provide a roadmap for developing and implementing an ethical deceased donation research framework that continually builds public trust. Although these recommendations can be applied to jurisdictions developing or reforming their organ and tissue donation and transplantation system, stakeholders are encouraged to collaborate and respond to their specific jurisdictional needs related to organ and tissue shortages.
RESUMEN
This 2023 Clinical Practice Guideline provides the biomedical definition of death based on permanent cessation of brain function that applies to all persons, as well as recommendations for death determination by circulatory criteria for potential organ donors and death determination by neurologic criteria for all mechanically ventilated patients regardless of organ donation potential. This Guideline is endorsed by the Canadian Critical Care Society, the Canadian Medical Association, the Canadian Association of Critical Care Nurses, Canadian Anesthesiologists' Society, the Canadian Neurological Sciences Federation (representing the Canadian Neurological Society, Canadian Neurosurgical Society, Canadian Society of Clinical Neurophysiologists, Canadian Association of Child Neurology, Canadian Society of Neuroradiology, and Canadian Stroke Consortium), Canadian Blood Services, the Canadian Donation and Transplantation Research Program, the Canadian Association of Emergency Physicians, the Nurse Practitioners Association of Canada, and the Canadian Cardiovascular Critical Care Society.
RéSUMé: Ces Lignes directrices de pratique clinique 2023 Lignes directrices de pratique clinique dicale du décès basée sur l'arrêt permanent de la fonction cérébrale qui s'applique à toute personne, ainsi que des recommandations pour la détermination du décès par des critères circulatoires pour des donneurs d'organes potentiels et des recommandations pour la détermination du décès par des critères neurologiques pour tous les patients sous ventilation mécanique, indépendamment de leur potentiel de donneur d'organes. Les présentes Lignes directrices sont approuvées par la Société canadienne de soins intensifs, l'Association médicale canadienne, l'Association canadienne des infirmiers/infirmières en soins intensifs, la Société canadienne des anesthésiologistes, la Fédération des sciences neurologiques du Canada (représentant la Société canadienne de neurologie, la Société canadienne de neurochirurgie, la Société canadienne de neurophysiologie clinique, l'Association canadienne de neurologie pédiatrique, la Société canadienne de neuroradiologie et le Consortium neurovasculaire canadien), la Société canadienne du sang, le Programme de recherche en don et transplantation du Canada, l'Association canadienne des médecins d'urgence, l'Association des infirmières et infirmiers praticiens du Canada, et la Société canadienne de soins intensifs cardiovasculaires (CANCARE) et la Société canadienne de pédiatrie.
Asunto(s)
Médicos , Obtención de Tejidos y Órganos , Niño , Humanos , Canadá , Donantes de Tejidos , Encéfalo , Muerte , Muerte Encefálica/diagnósticoRESUMEN
PURPOSE: Variability in practice exists in death determination by circulatory criteria in the context of organ donation. We sought to describe the practices of intensive care health care professionals for death determination by circulatory criteria with and without organ donation. METHODS: This study is a retrospective analysis of prospectively collected data. We included patients with death determination by circulatory criteria in intensive care units at 16 hospitals in Canada, three in the Czech Republic, and one in the Netherlands. Results were recorded using a checklist for the determination of death questionnaire. RESULTS: A total of 583 patients had their death determination checklist reviewed for statistical analysis. The mean (standard deviation) age in years was 64 (15). Three hundred and fourteen (54.0%) patients were from Canada, 230 (39.5%) were from the Czech Republic, and 38 (6.5%) were from the Netherlands. Fifty-two (8.9%) patients proceeded with donation after death determination by circulatory criteria (DCD). The most common diagnostic tests reported for the whole group were absent heart sounds by auscultation (81.8%), flat continuous arterial blood pressure (ABP) tracing (77.0%), and flat electrocardiogram tracing (73.2%). In patients who successfully underwent DCD (N = 52), death was determined most frequently using a flat continuous ABP tracing (94%), absent pulse oximetry (85%), and absent palpable pulse (77%). CONCLUSION: In this study, we have described practices for death determination by circulatory criteria both within and between countries. Though some variability exists, we are reassured that appropriate criteria are almost always used in the context of organ donation. In particular, the use of continuous ABP monitoring in DCD was consistent. It highlights the need for standardization of practice and up to date guidelines, especially within the context of DCD where there is both an ethical and a legal requirement to adhere to the dead donor rule, while minimizing time between death determination and organ procurement.
RéSUMé: OBJECTIF: Il existe de la variabilité dans la pratique en matière de détermination du décès selon des critères circulatoires dans le contexte d'un don d'organes. Nous avons cherché à décrire les pratiques des professionnels de la santé en soins intensifs en ce qui touche à la détermination du décès selon des critères circulatoires avec et sans don d'organes. MéTHODE: Cette étude est une analyse rétrospective de données recueillies prospectivement. Nous avons inclus des patients dont le décès avait été déterminé par des critères circulatoires dans les unités de soins intensifs de 16 hôpitaux au Canada, trois en République tchèque et un aux Pays-Bas. Les résultats ont été consignés à l'aide de la liste de contrôle d'un questionnaire sur la détermination du décès. RéSULTATS: Au total, les listes de contrôle pour la détermination du décès de 583 patients ont été examinées à des fins d'analyse statistique. L'âge moyen (écart type) en années était de 64 ans (15). Trois cent quatorze (54,0 %) patients provenaient du Canada, 230 (39,5 %) de la République tchèque et 38 (6,5 %) des Pays-Bas. Cinquante-deux (8,9 %) patients ont procédé au don après la détermination du décès selon des critères circulatoires (DCC). Les tests diagnostiques les plus fréquemment rapportés pour l'ensemble du groupe étaient l'absence de bruits cardiaques à l'auscultation (81,8 %), le tracé plat continu de la tension artérielle (TA) (77,0 %) et le tracé plat à l'électrocardiogramme (73,2 %). Chez les patients ayant été soumis avec succès à un DCD (N = 52), le décès a été déterminé le plus souvent à l'aide d'un tracé continu plat de la TA (94 %), d'une oxymétrie de pouls absente (85 %) et d'un pouls palpable absent (77 %). CONCLUSION: Dans cette étude, nous avons décrit les pratiques de détermination du décès selon des critères circulatoires à la fois à l'intérieur et entre les pays. Bien qu'il existe une certaine variabilité, nous sommes rassurés par le fait que des critères appropriés sont presque toujours utilisés dans le contexte du don d'organes. En particulier, l'utilisation du monitorage continu de la TA était constant en cas de DCC. Cela souligne la nécessité de normaliser la pratique et de disposer de lignes directrices mises à jour, en particulier dans le contexte de DCC où il existe une exigence à la fois éthique et légale de respecter la règle du donneur décédé, tout en minimisant le temps entre la détermination du décès et la collecte d'organes.
Asunto(s)
Muerte , Obtención de Tejidos y Órganos , Humanos , Unidades de Cuidados Intensivos , Estudios Retrospectivos , Donantes de Tejidos , Persona de Mediana EdadRESUMEN
PURPOSE: Current practice in organ donation after death determination by circulatory criteria (DCD) advises a five-minute observation period following circulatory arrest, monitoring for unassisted resumption of spontaneous circulation (i.e., autoresuscitation). In light of newer data, the objective of this updated systematic review was to determine whether a five-minute observation time was still adequate for death determination by circulatory criteria. SOURCE: We searched four electronic databases from inception to 28 August 2021, for studies evaluating or describing autoresuscitation events after circulatory arrest. Citation screening and data abstraction were conducted independently and in duplicate. We assessed certainty in evidence using the GRADE framework. PRINCIPAL FINDINGS: Eighteen new studies on autoresuscitation were identified, consisting of 14 case reports and four observational studies. Most studies evaluated adults (n = 15, 83%) and patients with unsuccessful resuscitation following cardiac arrest (n = 11, 61%). Overall, autoresuscitation was reported to occur between one and 20 min after circulatory arrest. Among all eligible studies identified by our reviews (n = 73), seven observational studies were identified. In observational studies of controlled withdrawal of life-sustaining measures with or without DCD (n = 6), 19 autoresuscitation events were reported in 1,049 patients (incidence 1.8%; 95% confidence interval, 1.1 to 2.8). All resumptions occurred within five minutes of circulatory arrest and all patients with autoresuscitation died. CONCLUSION: A five-minute observation time is sufficient for controlled DCD (moderate certainty). An observation time greater than five minutes may be needed for uncontrolled DCD (low certainty). The findings of this systematic review will be incorporated into a Canadian guideline on death determination. STUDY REGISTRATION: PROSPERO (CRD42021257827); registered 9 July 2021.
RéSUMé: OBJECTIF: La pratique actuelle en matière de don d'organes après une détermination du décès par critères circulatoires (DCC) préconise une période d'observation de cinq minutes après l'arrêt circulatoire et le monitorage de la reprise non assistée de la circulation spontanée (c.-à-d. l'auto-réanimation). À la lumière de données plus récentes, l'objectif de cette revue systématique mise à jour était de déterminer si un temps d'observation de cinq minutes était toujours suffisant pour une détermination de décès selon des critères circulatoires (DCC). SOURCES: Nous avons effectué des recherches dans quatre bases de données électroniques depuis leur création jusqu'au 28 août 2021 pour en tirer les études évaluant ou décrivant des événements d'autoréanimation après un arrêt circulatoire. L'examen des citations et l'extraction des données ont été réalisés de manière indépendante et en double. Nous avons évalué la certitude des données probantes à l'aide de la méthodologie GRADE. CONSTATATIONS PRINCIPALES: Dix-huit nouvelles études sur l'autoréanimation ont été identifiées, comprenant 14 présentations de cas et quatre études observationnelles. La plupart des études ont évalué des adultes (n = 15, 83 %) et les patients dont la réanimation avait échoué à la suite d'un arrêt cardiaque (n = 11, 61 %). Dans l'ensemble, l'autoréanimation a été signalée entre une et 20 minutes après l'arrêt circulatoire. Parmi toutes les études admissibles identifiées par nos comptes rendus (n = 73), sept études observationnelles ont été identifiées. Dans les études observationnelles sur l'interruption contrôlée des thérapies de maintien des fonctions vitales avec ou sans DCC (n = 6), 19 événements d'autoréanimation ont été rapportés chez 1049 patients (incidence 1,8 % ; intervalle de confiance à 95 %, 1,1 à 2,8). Toutes les reprises ont eu lieu dans les cinq minutes suivant l'arrêt circulatoire et tous les patients en autoréanimation sont décédés. CONCLUSION: Un temps d'observation de cinq minutes est suffisant pour un DCC contrôlé (certitude modérée). Un temps d'observation supérieur à cinq minutes peut être nécessaire en cas de DDC non contrôlé (faible certitude). Les résultats de cette revue systématique seront intégrés à des lignes directrices canadienne de pratique clinique sur la détermination du décès. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42021257827); enregistrée le 9 juillet 2021.
Asunto(s)
Reanimación Cardiopulmonar , Paro Cardíaco , Obtención de Tejidos y Órganos , Adulto , Humanos , Retorno de la Circulación Espontánea , Muerte , Canadá , Paro Cardíaco/terapiaRESUMEN
PURPOSE: Currently, there is little empirical data on family understanding about brain death and death determination. The purpose of this study was to describe family members' (FMs') understanding of brain death and the process of determining death in the context of organ donation in Canadian intensive care units (ICUs). METHODS: We conducted a qualitative study using semistructured, in-depth interviews with FMs who were asked to make an organ donation decision on behalf of adult or pediatric patients with death determination by neurologic criteria (DNC) in Canadian ICUs. RESULTS: From interviews with 179 FMs, six main themes emerged: 1) state of mind, 2) communication, 3) DNC may be counterintuitive, 4) preparation for the DNC clinical assessment, 5) DNC clinical assessment, and 6) time of death. Recommendations on how clinicians can help FMs to understand and accept DNC through communication at key moments were described including preparing FMs for death determination, allowing FMs to be present, and explaining the legal time of death, combined with multimodal strategies. For many FMs, understanding of DNC unfolded over time, facilitated with repeated encounters and explanation, rather than during a single meeting. CONCLUSION: Family members' understanding of brain death and death determination represented a journey that they reported in sequential meeting with health care providers, most notably physicians. Modifiable factors to improve communication and bereavement outcomes during DNC include attention to the state of mind of the family, pacing and repeating discussions according to families' expressed understanding, and preparing and inviting families to be present for the clinical determination including apnea testing. We have provided family-generated recommendations that are pragmatic and can be easily implemented.
RéSUMé: OBJECTIF: À l'heure actuelle, il y a peu de données empiriques sur la compréhension des familles de la mort cérébrale et de la détermination du décès. Le but de cette étude était de décrire la compréhension des membres de la famille de la mort cérébrale et du processus de détermination du décès dans le contexte du don d'organes dans les unités de soins intensifs (USI) canadiennes. MéTHODE: Nous avons mené une étude qualitative à l'aide d'entrevues semi-structurées et approfondies avec des membres de la famille à qui on a demandé de prendre une décision de don d'organes au nom de patients adultes ou pédiatriques dont le décès avait été déterminé selon des critères neurologiques (DCN) dans les unités de soins intensifs canadiennes. RéSULTATS: Sur la base d'entrevues avec 179 membres de la famille, six thèmes principaux ont émergé : 1) l'état d'esprit, 2) la communication, 3) le DCN peut être contre-intuitif, 4) la préparation à l'évaluation clinique pour un DCN, 5) l'évaluation clinique pour un DCN et 6) le moment du décès. Des recommandations sur la façon dont les cliniciens peuvent aider les membres de la famille à comprendre et à accepter un DCN par la communication à des moments clés ont été décrites, y compris la préparation des membres de la famille à la détermination du décès, l'autorisation de la présence des membres de la famille et l'explication de l'heure légale du décès, combinées à des stratégies multimodales. Pour de nombreux membres de la famille, la compréhension du DCN s'est développée au fil du temps et a été facilitée par des rencontres et des explications répétées plutôt qu'au cours d'une seule rencontre. CONCLUSION: La compréhension qu'ont les membres de la famille de la mort cérébrale et de la détermination du décès représente un parcours qu'ils ont décrit lors de rencontres successives avec des acteurs de soins de santé, et particulièrement avec des médecins. Les facteurs modifiables pour améliorer la communication et les issues du deuil pendant un DCN comprennent l'attention portée à l'état d'esprit de la famille, le rythme et la répétition des discussions en fonction de la compréhension exprimée par les familles, ainsi que la préparation et l'invitation des familles à être présentes pour la détermination clinique, y compris pendant le test d'apnée. Nous avons fourni des recommandations familiales qui sont pragmatiques et peuvent être facilement mises en Åuvre.