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1.
N Engl J Med ; 389(22): 2029-2038, 2023 Nov 30.
Artículo en Inglés | MEDLINE | ID: mdl-38048188

RESUMEN

BACKGROUND: Hemodynamic instability and myocardial dysfunction are major factors preventing the transplantation of hearts from organ donors after brain death. Intravenous levothyroxine is widely used in donor care, on the basis of observational data suggesting that more organs may be transplanted from donors who receive hormonal supplementation. METHODS: In this trial involving 15 organ-procurement organizations in the United States, we randomly assigned hemodynamically unstable potential heart donors within 24 hours after declaration of death according to neurologic criteria to open-label infusion of intravenous levothyroxine (30 µg per hour for a minimum of 12 hours) or saline placebo. The primary outcome was transplantation of the donor heart; graft survival at 30 days after transplantation was a prespecified recipient safety outcome. Secondary outcomes included weaning from vasopressor therapy, donor ejection fraction, and number of organs transplanted per donor. RESULTS: Of the 852 brain-dead donors who underwent randomization, 838 were included in the primary analysis: 419 in the levothyroxine group and 419 in the saline group. Hearts were transplanted from 230 donors (54.9%) in the levothyroxine group and 223 (53.2%) in the saline group (adjusted risk ratio, 1.01; 95% confidence interval [CI], 0.97 to 1.07; P = 0.57). Graft survival at 30 days occurred in 224 hearts (97.4%) transplanted from donors assigned to receive levothyroxine and 213 hearts (95.5%) transplanted from donors assigned to receive saline (difference, 1.9 percentage points; 95% CI, -2.3 to 6.0; P<0.001 for noninferiority at a margin of 6 percentage points). There were no substantial between-group differences in weaning from vasopressor therapy, ejection fraction on echocardiography, or organs transplanted per donor, but more cases of severe hypertension and tachycardia occurred in the levothyroxine group than in the saline group. CONCLUSIONS: In hemodynamically unstable brain-dead potential heart donors, intravenous levothyroxine infusion did not result in significantly more hearts being transplanted than saline infusion. (Funded by Mid-America Transplant and others; ClinicalTrials.gov number, NCT04415658.).


Asunto(s)
Muerte Encefálica , Trasplante de Corazón , Tiroxina , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Encéfalo , Tiroxina/administración & dosificación , Administración Intravenosa , Hemodinámica
2.
Pediatr Transplant ; 27(4): e14514, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36945079

RESUMEN

BACKGROUND: Children awaiting transplantation face a high risk of waitlist mortality due to a shortage of pediatric organ donors. Pediatric donation consent rates vary across Organ Procurement Organizations (OPOs), suggesting that some OPOs might utilize more effective pediatric-focused donor recruitment techniques than others. An online survey of 193 donation requestor staff sheds light on the strategies that OPO staff utilize when approaching potential pediatric deceased organ donors. METHODS: In collaboration with the Association of Organ Procurement Organizations, the research team contacted the executive directors and medical directors of all 57 of the OPOs in the US. Of these, 51 OPOs agreed to participate, and 47 provided contact information for donation requestor staff. Of the 379 staff invited to participate in the survey, 193 provided complete responses. RESULTS: Respondents indicated more comfort approaching adult donors than pediatric donors, and they endorsed approach techniques that were interpersonal and emotional rather than professional and informative. Respondents were accurate in their perceptions about which donor characteristics are associated with consent. However, respondents from OPOs with high consent rates (according to data from the Scientific Registry of Transplant Recipients), and those from OPOs with low consent rates were very similar in terms of demographics, training, experience, and reported techniques. CONCLUSIONS: Additional research is needed to better determine why some OPOs have higher consent rates than others and whether the factors that lead to high consent rates in high-performing OPOs can be successful when implemented by lower-performing OPOs.


Asunto(s)
Trasplante de Órganos , Obtención de Tejidos y Órganos , Adulto , Humanos , Niño , Donantes de Tejidos , Encuestas y Cuestionarios , Consentimiento Informado
3.
J Heart Lung Transplant ; 42(5): 627-636, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36868968

RESUMEN

BACKGROUND: Lack of donor organ availability represents a major limitation to the success of solid organ transplantation. The Scientific Registry of Transplant Recipients (SRTR) publishes performance reports of organ procurement organizations (OPO) in the United States, but does not stratify by the mechanism of donor consent, namely first-person authorization (organ donor registry) and next-of-kin authorization. This study aimed to report the trends in deceased organ donation in the United States and assess the regional differences in OPO performance after accounting for the different mechanisms of donor consent. METHODS: The SRTR database was queried for all eligible deaths (2008-2019) which were then stratified based on the mechanism of donor authorization. Multivariable logistic regression was performed to assess the probability of organ donation across OPOs based on specific donor consent mechanisms. Eligible deaths were divided into 3 cohorts based on the probability to donate. Consent rates at the OPO level were calculated for each cohort. RESULTS: Organ donor registration among adult eligible deaths in the U.S. increased over time (2008: 10% vs 2019: 39%, p < 0.001), coincident with a decline in next-of-kin authorization rates (2008: 70% vs 2019: 64%, p < 0.001). At the OPO level, the increased organ donor registration was associated with lower next-of-kin authorization rates. Among eligible deaths with medium- and low-probability of donation, recruitment was highly variable across OPO's, ranging from 36% to 75% in the medium-probability group (median 54%, IQR 50%-59%) and 8% and 73% in the low-probability group (median 30%, IQR 17%-38%). CONCLUSION: Significant variability exists across OPOs in the consent of potentially persuadable donors after adjusting for population demographic differences and the mechanism of consent. Current metrics may not truly reflect OPO performance as they do not account for consent mechanism. There is further opportunity for improvement in deceased organ donation through targeted initiatives across OPOs, modeled after regions with the best performance.


Asunto(s)
Trasplante de Órganos , Obtención de Tejidos y Órganos , Adulto , Humanos , Estados Unidos/epidemiología , Donantes de Tejidos , Sistema de Registros , Consentimiento Informado
4.
Transplant Proc ; 54(8): 2075-2081, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36357226

RESUMEN

Patients on the transplant waiting list continue to have a significant wait time as organ supply remains low. Many initiatives have been undertaken in the last few years to attempt to increase the organ allograft supply. As organ procurement organizations have attempted to increase their procurement of organs from deceased donors, emphasis has been placed on avoidance of injury to organs during procurement. To analyze the success of this attention, data were collected from 29 of 57 organ procurement organizations in the United States. Data collection was from November 2017 to January 2020. Total injury rate ranged from 6% (donation after brain death) to 8.4% (donation after circulatory death). Level 3 injuries, those resulting in loss of the allograft, ranged from 1.1% in donation after brain death to 1.6% in donation after circulatory death. The most likely injured organ resulting in loss of viability (level 3 injury) during procurement was the right kidney. We noted that among donors with procurement injuries, a higher number had no previous abdominal surgery and there were more injuries noted from attending surgeons (compared to trainees). Deceased donor procurement organ injuries, though rare, lead to substantial loss of transplantable organs every year. Given that the United Network for Organ Sharing has recorded >10,000 deceased donors yearly for the past few years, such injuries can result in hundreds of transplantable organs lost. In this article we detailed the incidence and degree of injury and some variables that may be associated with these injuries.


Asunto(s)
Muerte Encefálica , Obtención de Tejidos y Órganos , Humanos , Estados Unidos , Donantes de Tejidos , Riñón , Recolección de Datos
5.
Pediatrics ; 147(6)2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33963074

RESUMEN

BACKGROUND: A shortage of donor organs represents the major barrier to the success of solid organ transplantation. This is especially true in the pediatric population for which the number of organ donors has decreased over time. With this study, we aimed to assess the factors associated with deceased organ donor consent in the pediatric population and determine the variability in consent rates across organ procurement organizations (OPOs). METHODS: All eligible pediatric deaths were identified from the Scientific Registry of Transplant Recipients (2008-2019). The rate of organ donor consent was determined, and multivariable logistic regression was used to assess the factors independently associated with successful donor recruitment. The probability of donor consent was determined for each OPO after adjusting for patient demographics. RESULTS: A total of 11 829 eligible pediatric deaths were approached to request consent for organ donation. Consent was successful in 8816 (74.5%) subjects. Consent rates are lower in the pediatric population compared with young adults and are directly related to patient age such that eligible infant deaths have the lowest rate of successful donor consent. There is significant variability in donor consent rates across OPOs, independent of population demographic differences. CONCLUSIONS: OPO is predictive of pediatric deceased organ donor consent independent of demographic differences, with some regions having consistently higher consent rates than others. Sharing best practices for pediatric deceased donor recruitment may be a strategy to increase organ availability in the pediatric population.


Asunto(s)
Obtención de Tejidos y Órganos/estadística & datos numéricos , Adolescente , Cadáver , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino
6.
Ann Surg ; 274(6): e610-e615, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-31804390

RESUMEN

OBJECTIVE: To determine if addition of the S-nitrosylating agent ethyl nitrite (ENO) to the preservation solution can improve perfusion parameters in pumped human kidneys. BACKGROUND: A significant percentage of actively stored kidneys experience elevations in resistance and decreases in flow rate during the ex vivo storage period. Preclinical work indicates that renal status after brain death is negatively impacted by inflammation and reduced perfusion-processes regulated by protein S-nitrosylation. To translate these findings, we added ENO to the preservation solution in an attempt to reverse the perfusion deficits observed in nontransplanted pumped human kidneys. METHODS: After obtaining positive proof-of-concept results with swine kidneys, we studied donated human kidneys undergoing hypothermic pulsatile perfusion deemed unsuitable for transplantation. Control kidneys continued to be pumped a 4°C (ie, standard of care). In the experimental group, the preservation solution was aerated with 50 ppm ENO in nitrogen. Flow rate and perfusion were recorded for 10 hours followed by biochemical analysis of the kidney tissue. RESULTS: In controls, perfusion was constant during the monitoring period (ie, flow rate remained low and resistance stayed high). In contrast, the addition of ENO produced significant and sustained reductions in resistance and increases in flow rate. ENO-treated kidneys had higher levels of cyclic guanosine monophosphate, potentially explaining the perfusion benefits, and increased levels of interleukin-10, suggestive of an anti-inflammatory effect. CONCLUSIONS: S-Nitrosylation therapy restored the microcirculation and thus improved overall organ perfusion. Inclusion of ENO in the renal preservation solution holds promise to increase the number and quality of kidneys available for transplant.


Asunto(s)
Riñón/irrigación sanguínea , Microcirculación , Nitritos/administración & dosificación , Soluciones Preservantes de Órganos/administración & dosificación , Preservación de Órganos/métodos , Animales , GMP Cíclico/metabolismo , Humanos , Interleucina-10/metabolismo , Riñón/metabolismo , Óxido Nítrico/metabolismo , Prueba de Estudio Conceptual , Porcinos
7.
J Heart Lung Transplant ; 39(11): 1220-1227, 2020 11.
Artículo en Inglés | MEDLINE | ID: mdl-32773324

RESUMEN

BACKGROUND: The direCt Lung Ultrasound Evaluation (CLUE) technique was proven to be an accurate method for monitoring extravascular lung water in donor lungs during ex vivo lung perfusion (EVLP) in an experimental model. The aim of this study was to examine the application of CLUE in the clinical setting. METHODS: Lungs were evaluated using acellular EVLP protocol. Ultrasound images were obtained directly from the lung surface. Images were graded according to the percentage of B-lines seen on ultrasound. CLUE scores were calculated at the beginning and end of EVLP for the whole lung, each side, and lobe based on the number (No.) of images in each grade and the total No. of images taken and evaluated retrospectively. RESULTS: A total of 23 EVLP cases were performed resulting in 13 lung transplants (LTxs) with no hospital mortality. Primary graft dysfunction (PGD) occurred in only 1 recipient (PGD3, no PGD2). Significant differences were found between suitable and non-suitable lungs in CLUE scores (1.03 vs 1.85, p < 0.001), unlike the partial pressure of oxygen/fraction of inspired oxygen ratio. CLUE had the highest area under the receiver operating characteristic curve (0.98) compared with other evaluation parameters. The initial CLUE score of standard donor lungs was significantly better than marginal lungs. The final CLUE score in proned lungs showed improvement when compared with initial CLUE score, especially in the upper lobes. CONCLUSIONS: The CLUE technique shows the highest accuracy in evaluating donor lungs for LTx suitability compared with other parameters used in EVLP. CLUE can optimize the outcomes of LTx by guiding the decision making through the whole process of clinical EVLP.


Asunto(s)
Circulación Extracorporea/métodos , Trasplante de Pulmón , Perfusión/métodos , Disfunción Primaria del Injerto/prevención & control , Donantes de Tejidos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Disfunción Primaria del Injerto/diagnóstico , Curva ROC , Estudios Retrospectivos , Ultrasonografía
8.
Clin Transplant ; 34(10): e14035, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32654227

RESUMEN

Donation after circulatory death (DCD) liver allografts remain underutilized. Inconsistent processes for DCD procurement may contribute to allograft discard. Optimal surgical and organ procurement organization (OPO) practices for DCD liver recovery should be developed and adopted. DCD practice surveys were distributed to transplant surgeons and OPO leadership. DCD liver recovery best practices were assembled based on survey data, literature review, and subject-matter expert consensus opinion. Data were obtained from transplant surgeons (n = 188) and OPO leadership (n = 48 OPOs). Surgeons preferred attending physician presence at recovery (72.4%); while only 27.7% of OPOs require this. Pre-withdrawal communication huddle (Surgeons: 88.7%; OPOs: 93.8%) and administration of pre-withdrawal heparin (Surgeons: 90.6%; OPOs: 84.8%) are widely accepted. Surgical preference for withdrawal of support is in the operating room (89.3%); OPO practice varies dependent upon hospital and family requirements. Functional donor warm ischemic time (fDWIT) start time is variable, while fDWIT end time is agreed upon as initiation of aortic flush by surgeons (81%) and OPOs (81%). DCD liver recovery practices including mandatory communication huddle, pre-withdrawal heparin administration, and clearly defined start and end of fDWIT should be implemented nationally. Creating a set of best practices for DCD recovery guidelines is necessary for improving DCD liver utilization.


Asunto(s)
Cirujanos , Obtención de Tejidos y Órganos , Muerte , Humanos , Hígado , Estándares de Referencia , Donantes de Tejidos , Estados Unidos
9.
J Heart Lung Transplant ; 38(7): 757-766, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31000373

RESUMEN

BACKGROUND: Extravascular lung water (EVLW) could change in donor lungs in a time-dependent fashion during procurement or ex-vivo lung perfusion (EVLP) and may vary across different zones. Current techniques for EVLW assessment are either subjective, general estimation, or not feasible in the clinical setting. An accurate and non-invasive diagnostic tool for EVLW would be desirable for donor lung assessment and management. Therefore, we studied the feasibility and accuracy of direCt Lung Ultrasound Evaluation (CLUE) technique. METHODS: Eleven lungs were utilized for the human model and 6 lungs for the porcine model. Lungs underwent EVLP for 2 hours. In CLUE, ultrasound images were taken directly from the lungs. A scoring system was created for each point based on the percentage of B-lines. Images were graded according to the degree of edema. An equation was used to calculate total lung and lobe scores based on number of images of each grade. RESULTS: CLUE point score correlated with wet/dry ratio in human and porcine models (n = 99, r = 0.863, p < 0.001; and n = 31, r = 0.916, p < 0.001, respectively). CLUE total lung score correlated with lung weight (n = 19, r = 0.812, p < 0.001; and n = 12, r = 0.895, p < 0.001, respectively). CLUE lobe score correlated negatively with partial pressure of oxygen/fraction of inspired oxygen ratio in the human model (n = 20, r = -0.775, p < 0.001). CONCLUSIONS: EVLW monitoring in donor lungs with CLUE after procurement is feasible and CLUE scores were found to be significantly correlated with lung weight, wet/dry, and PaO2/FIO2 ratio.


Asunto(s)
Agua Pulmonar Extravascular/diagnóstico por imagen , Pulmón/diagnóstico por imagen , Adulto , Anciano , Animales , Estudios de Factibilidad , Femenino , Humanos , Pulmón/cirugía , Trasplante de Pulmón , Masculino , Persona de Mediana Edad , Modelos Animales , Neumonectomía , Reproducibilidad de los Resultados , Porcinos , Ultrasonografía/métodos
10.
J Crit Care ; 48: 42-47, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30172032

RESUMEN

PURPOSE: We sought to build prediction models for organ transplantation and recipient survival using both biomarkers and clinical information. MATERIALS AND METHODS: We abstracted clinical variables from a previous randomized trial (n = 556) of donor management. In a subset of donors (n = 97), we measured two candidate biomarkers in plasma at enrollment and just prior to explantation. RESULTS: Secretory leukocyte protease inhibitor (SLPI) was significant for predicting liver transplantation (C-statistic 0.65 (0.53, 0.78)). SLPI also significantly improved the predictive performance of a clinical model for liver transplantation (integrated discrimination improvement (IDI): 0.090 (0.009, 0.210)). For other organs, clinical variables alone had strong predictive ability (C-statistic >0.80). Recipient 3-years survival was 80.0% (71.9%, 87.0%). Donor IL-6 was significantly associated with recipient 3-years survival (adjusted Hazard Ratio (95%CI): 1.26(1.08, 1.48), P = .004). Neither clinical variables nor biomarkers showed strong predictive ability for 3-year recipient survival. CONCLUSIONS: Plasma biomarkers in neurologically deceased donors were associated with organ use. SLPI enhanced prediction within a liver transplantation model, whereas IL-6 before transplantation was significantly associated with recipient 3-year survival. Clinicaltrials.gov: NCT00987714.


Asunto(s)
Muerte Encefálica/inmunología , Interleucina-6/sangre , Trasplante de Órganos/mortalidad , Inhibidor Secretorio de Peptidasas Leucocitarias/sangre , Obtención de Tejidos y Órganos/métodos , Adulto , Biomarcadores/sangre , Femenino , Rechazo de Injerto/inmunología , Supervivencia de Injerto/inmunología , Humanos , Masculino , Persona de Mediana Edad
11.
Semin Cardiothorac Vasc Anesth ; 22(2): 211-222, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29276852

RESUMEN

Worldwide 715 482 patients have received a lifesaving organ transplant since 1988. During this time, there have been advances in donor management and in the perioperative care of the organ transplant recipient, resulting in marked improvements in long-term survival. Although the number of organs recovered has increased year after year, a greater demand has produced a critical organ shortage. The majority of organs are from deceased donors; however, some are not suitable for transplantation. Some of this loss is due to management of the donor. Improved donor care may increase the number of available organs and help close the existing gap in supply and demand. In order to address this concern, The Organ Donation and Transplantation Alliance, the Association of Organ Procurement Organizations, and the Transplant and Critical Care Committees of the American Society of Anesthesiologists have formulated evidence-based guidelines, which include a call for greater involvement and oversight by anesthesiologists and critical care specialists, as well as uniform reporting of data during organ procurement and recovery.


Asunto(s)
Anestesia/métodos , Muerte Encefálica , Consenso , Donantes de Tejidos , Obtención de Tejidos y Órganos , Cuidados Críticos , Fluidoterapia , Humanos , Resucitación
13.
Prog Transplant ; 26(3): 210-4, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-27312683

RESUMEN

CONTEXT: Lung transplantation is limited by donor lung availability with ∼20% of deceased donor lungs transplanted. Diagnostic testing identifying pulmonary derangements guide donor management strategies to maximize lung transplantation. Lung ultrasound (LUS) identifies pathology in critically ill patients equivalent or superior to chest radiograph (CXR) or computed tomography (CT) scans. No published studies have reported on LUS in neurologically deceased donors (DNDDs). OBJECTIVE: We evaluated LUS in identifying abnormal lung pathology in DNDDs and related these findings to the standard approach. DESIGN: Prospective pilot study. SETTING: Intensive care units, university-associated teaching hospital. PARTICIPANTS: Six DNDDs evaluated during donor management. INTERVENTIONS: Deceased donors were enrolled based on the availability of ultrasound operators (USOs). Bedside LUS was performed using Lichtenstein 3- or Volpicelli 4-zone method based on the operator preference. Lungs were evaluated for sliding, A/B profile, consolidation, or pleural fluid. Ultrasound operators were blinded to donor management data. Lung ultrasound interpretations were compared for interindividual variability. Ultrasound and anteroposterior portable CXR (AP-CXR) results were compared by Organ Procurement Organization medical directors. MEASUREMENTS AND MAIN RESULTS: Bedside LUS compared well to AP-CXRs during donor management. There was no interindividual variability noted among USOs. Lung ultrasound identified all findings on AP-CXR and additional clinical pathology not reported on AP-CXR. Reports on AP-CXRs took a median 202 (13-696) minutes to occur, with LUS results available immediately. CONCLUSIONS: Lung ultrasound may play a significant role in donor management providing real-time clinical data, allowing for rapid identification of abnormalities, and leading to management interventions that may increase the number of transplanted lungs.


Asunto(s)
Trasplante de Pulmón , Pulmón/diagnóstico por imagen , Obtención de Tejidos y Órganos , Ultrasonografía , Australia , Humanos , Proyectos Piloto , Estudios Prospectivos
14.
Clin Transplant ; 29(12): 1173-80, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26448622

RESUMEN

Kidneys from donors after cardiac death (DCD) are at risk for inferior outcomes, possibly due to microthrombi and additional warm ischemia. We describe an organ procurement organization-wide trial utilizing thrombolytic tissue plasminogen activator (tPA) during machine pulsatile perfusion (MPP). A kidney from each recovered kidney pair was prospectively randomized to receive tPA (50 mg Alteplase) or no tPA (control) in the MPP perfusate. From 2011 to 2013, 24 kidneys were placed with enrolled recipients from 19 DCD kidney donors. There were no significant differences for absolute values of flow or resistance while undergoing MPP between the groups, nor rates of achieving discrete flow and resistance targets. While there was a trend toward lower creatinine and higher glomerular filtration rates in the tPA group at 3, 6, 9, and 12 months, these differences were not significant. Delayed graft function (DGF) rates were 41.7% in the tPA group vs. 58.4% in the control group (OR 0.51, 95%CI 0.10-2.59, p = 0.68). Death-censored graft survival was similar between the groups. In this pilot study, encouraging trends are seen in kidney allograft function independent of MPP parameters following DCD kidney transplantation for those kidneys receiving thrombolytic tPA and MPP, compared with standard MPP.


Asunto(s)
Muerte , Riñón/fisiología , Evaluación del Resultado de la Atención al Paciente , Terapia Trombolítica , Donantes de Tejidos , Obtención de Tejidos y Órganos , Adolescente , Adulto , Estudios de Casos y Controles , Niño , Funcionamiento Retardado del Injerto , Femenino , Estudios de Seguimiento , Tasa de Filtración Glomerular , Humanos , Pruebas de Función Renal , Masculino , Persona de Mediana Edad , Preservación de Órganos , Perfusión , Proyectos Piloto , Pronóstico , Estudios Prospectivos , Adulto Joven
15.
Crit Care Med ; 43(6): 1291-325, 2015 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-25978154

RESUMEN

This document was developed through the collaborative efforts of the Society of Critical Care Medicine, the American College of Chest Physicians, and the Association of Organ Procurement Organizations. Under the auspices of these societies, a multidisciplinary, multi-institutional task force was convened, incorporating expertise in critical care medicine, organ donor management, and transplantation. Members of the task force were divided into 13 subcommittees, each focused on one of the following general or organ-specific areas: death determination using neurologic criteria, donation after circulatory death determination, authorization process, general contraindications to donation, hemodynamic management, endocrine dysfunction and hormone replacement therapy, pediatric donor management, cardiac donation, lung donation, liver donation, kidney donation, small bowel donation, and pancreas donation. Subcommittees were charged with generating a series of management-related questions related to their topic. For each question, subcommittees provided a summary of relevant literature and specific recommendations. The specific recommendations were approved by all members of the task force and then assembled into a complete document. Because the available literature was overwhelmingly comprised of observational studies and case series, representing low-quality evidence, a decision was made that the document would assume the form of a consensus statement rather than a formally graded guideline. The goal of this document is to provide critical care practitioners with essential information and practical recommendations related to management of the potential organ donor, based on the available literature and expert consensus.


Asunto(s)
Unidades de Cuidados Intensivos/organización & administración , Guías de Práctica Clínica como Asunto , Donantes de Tejidos , Obtención de Tejidos y Órganos/organización & administración , Muerte , Humanos , Unidades de Cuidados Intensivos/normas , Derechos del Paciente , Sociedades Médicas , Obtención de Tejidos y Órganos/normas , Estados Unidos
16.
Intensive Care Med ; 41(3): 418-26, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25583616

RESUMEN

BACKGROUND: Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. METHODS: We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. RESULTS: We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). CONCLUSIONS: In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.


Asunto(s)
Muerte Encefálica , Protocolos Clínicos , Fluidoterapia/normas , Donantes de Tejidos , Obtención de Tejidos y Órganos/normas , Adulto , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos
17.
Crit Care Resusc ; 15(3): 234-40, 2013 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-23944211

RESUMEN

BACKGROUND: Despite efforts to increase organ donation, there remain critical shortages in organ donors and organs procured per donor. Our trial is a large-scale, multicentre, randomised controlled trial in brain-dead donors, to compare protocolised care (using minimally invasive haemodynamic monitoring) with usual care. We describe the study design and discuss unique aspects of doing research in this population. METHODS: Our study will randomise brain-dead patients to protocolised or usual care. The primary end point is the number of organs transplanted per donor. Secondary end points include number of transplantable organs per donor, recipient 6-month hospital-free survival time, and the relationship between the level of interleukin-6 and the number and usability of organs transplanted. The primary analysis will be an intention-to-treat analysis; secondary analyses include modified intention-to-treat and as-treated analyses. The study will also compare the ratio of observed to expected number of organs transplanted per donor, by treatment arm, as a secondary end point. Preplanned subgroup analyses include restriction to extended criteria donors, and donors older or younger than 65 years. RESULTS AND CONCLUSIONS: Several unique challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the fields of organ donation and transplantation.


Asunto(s)
Muerte Encefálica , Protocolos Clínicos/normas , Unidades de Cuidados Intensivos , Monitoreo Fisiológico/métodos , Trasplante de Órganos/normas , Donantes de Tejidos/provisión & distribución , Obtención de Tejidos y Órganos/métodos , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados
18.
Crit Care Med ; 39(9): 2139-55, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21849823

RESUMEN

OBJECTIVE: To review and revise the 1987 pediatric brain death guidelines. METHODS: Relevant literature was reviewed. Recommendations were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. CONCLUSIONS AND RECOMMENDATIONS: 1) Determination of brain death in term newborns, infants, and children is a clinical diagnosis based on the absence of neurologic function with a known irreversible cause of coma. Because of insufficient data in the literature, recommendations for preterm infants <37 wks gestational age are not included in this guideline. 2) Hypotension, hypothermia, and metabolic disturbances should be treated and corrected and medications that can interfere with the neurologic examination and apnea testing should be discontinued allowing for adequate clearance before proceeding with these evaluations. 3) Two examinations, including apnea testing with each examination separated by an observation period, are required. Examinations should be performed by different attending physicians. Apnea testing may be performed by the same physician. An observation period of 24 hrs for term newborns (37 wks gestational age) to 30 days of age and 12 hrs for infants and children (>30 days to 18 yrs) is recommended. The first examination determines the child has met the accepted neurologic examination criteria for brain death. The second examination confirms brain death based on an unchanged and irreversible condition. Assessment of neurologic function after cardiopulmonary resuscitation or other severe acute brain injuries should be deferred for ≥24 hrs if there are concerns or inconsistencies in the examination. 4) Apnea testing to support the diagnosis of brain death must be performed safely and requires documentation of an arterial Paco2 20 mm Hg above the baseline and ≥60 mm Hg with no respiratory effort during the testing period. If the apnea test cannot be safely completed, an ancillary study should be performed. 5) Ancillary studies (electroencephalogram and radionuclide cerebral blood flow) are not required to establish brain death and are not a substitute for the neurologic examination. Ancillary studies may be used to assist the clinician in making the diagnosis of brain death a) when components of the examination or apnea testing cannot be completed safely as a result of the underlying medical condition of the patient; b) if there is uncertainty about the results of the neurologic examination; c) if a medication effect may be present; or d) to reduce the interexamination observation period. When ancillary studies are used, a second clinical examination and apnea test should be performed and components that can be completed must remain consistent with brain death. In this instance, the observation interval may be shortened and the second neurologic examination and apnea test (or all components that are able to be completed safely) can be performed at any time thereafter. 6) Death is declared when these criteria are fulfilled.


Asunto(s)
Muerte Encefálica/diagnóstico , Humanos
20.
Prog Transplant ; 15(2): 124-8, 2005 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-16013460

RESUMEN

PURPOSE: Increasing healthcare professionals' knowledge about organ and tissue donation; the national mandates regarding referral compliance; and the effect on donors, donor families, and transplant recipients is a challenging task. Physicians not routinely involved in organ donation or transplantation are some of the most difficult professionals for organ procurement organizations to access. A course for medical students was developed to initiate the transfer of information, comfort, and familiarity with the organ and tissue donation process. METHODS: Discussions with a local medical school revealed that little organized education on organ and tissue donation existed. An elective course was developed consisting of 2-hour lectures, once a week for 6 weeks. Topics included an overview of tissue and organ donation, history and significance of the current crisis, determination of brain death and its role in organ donation, tissue donation, pretransplant and posttransplant processes, ethical issues, and the donor family and recipient experience. RESULTS: A thorough course proposal was presented to the medical school's Chairman of Surgery and Chairman of Transplantation. The proposal was approved for first- and second-year medical students. CONCLUSION: Offering medical students a unique and comprehensive course may attract curious students who could become future champions for donation. This type of educational approach may significantly influence future interactions between physicians and organ procurement organizations. If more organ procurement organizations implement this type of program, the medical students' knowledge of donation will not only affect and benefit the local organ procurement organization's service area but other procurement organizations throughout the country as well.


Asunto(s)
Educación de Pregrado en Medicina/organización & administración , Relaciones Interprofesionales , Estudiantes de Medicina , Obtención de Tejidos y Órganos/organización & administración , Actitud del Personal de Salud , Muerte Encefálica , Comunicación , Curriculum , Familia/psicología , Conocimientos, Actitudes y Práctica en Salud , Necesidades y Demandas de Servicios de Salud , Humanos , Relaciones Interinstitucionales , Preservación de Órganos , Trasplante de Órganos , Educación del Paciente como Asunto , Rol del Médico , Proyectos Piloto , Desarrollo de Programa , Evaluación de Programas y Proyectos de Salud , Derivación y Consulta , Facultades de Medicina/organización & administración , Estudiantes de Medicina/psicología , Obtención de Tejidos y Órganos/ética
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