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BACKGROUND: POINCARE-2 trial aimed to assess the effectiveness of a strategy designed to tackle fluid overload through daily weighing and subsequent administration of treatments in critically ill patients. Even in highly standardized care settings, such as intensive care units, effectiveness of such a complex intervention depends on its actual efficacy but also on the extent of its implementation. Using a process evaluation, we aimed to provide understanding of the implementation, context, and mechanisms of change of POINCARE-2 strategy during the trial, to gain insight on its effectiveness and inform the decision regarding the dissemination of the intervention. METHODS: We conducted a mixed-method process evaluation following the Medical Research Council guideline. Both quantitative data derived from the trial, and qualitative data from semi-structured interviews with professionals were used to explain implementation, mechanisms of change of the POINCARE-2 strategy, as well as contextual factors potentially influencing implementation of the strategy. RESULTS: Score of actual exposure to the strategy ranged from 29.1 to 68.2% during the control period, and from 61.9 to 92.3% during the intervention period, suggesting both potential contamination and suboptimal fidelity to the strategy. Lack of appropriate weighing devices, lack of human resources dedicated to research, pre-trial rooted prescription habits, and anticipated knowledge of the strategy have been identified as the main barriers to optimal implementation of the strategy in the trial context. CONCLUSIONS: Both contamination and suboptimal fidelity to POINCARE-2 strategy raised concerns about a potential bias towards the null of intention-to-treat (ITT) analyses. However, optimal fidelity seemed reachable. Consequently, a clinical strategy should not be rejected solely on the basis of the negativity of ITT analyses' results. Our findings showed that, even in highly standardized care conditions, the implementation of clinical strategies may be hindered by numerous contextual factors, which demonstrates the critical importance of assessing the viability of an intervention, prior to any evaluation of its effectiveness. TRIAL REGISTRATION: Number NCT02765009.
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Enfermedad Crítica , Fluidoterapia , Equilibrio Hidroelectrolítico , Humanos , Enfermedad Crítica/terapia , Fluidoterapia/métodos , Fluidoterapia/normas , Equilibrio Hidroelectrolítico/fisiología , Unidades de Cuidados Intensivos , Cuidados Críticos/métodos , Evaluación de Procesos, Atención de Salud/métodos , Femenino , MasculinoRESUMEN
BACKGROUND: The severity and course of sepsis-associated acute kidney injury (SA-AKI) are correlated with the mortality rate. Early detection of SA-AKI subphenotypes might facilitate the rapid provision of individualized care. PATIENTS AND METHODS: In this post-hoc analysis of a multicenter prospective study, we combined conventional kidney function variables with serial measurements of urine (tissue inhibitor of metalloproteinase-2 [TIMP-2])* (insulin-like growth factor-binding protein [IGFBP7]) at 0, 6, 12, and 24 h) and then using an unsupervised hierarchical clustering of principal components (HCPC) approach to identify different phenotypes of SA-AKI. We then compared the subphenotypes with regard to a composite outcome of in-hospital death or the initiation of renal replacement therapy (RRT). RESULTS: We included 184 patients presenting SA-AKI within 6 h of the initiation of catecholamines. Three distinct subphenotypes were identified: subphenotype A (99 patients) was characterized by a normal urine output (UO), a low SCr and a low [TIMP-2]*[IGFBP7] level; subphenotype B (74 patients) was characterized by existing chronic kidney disease (CKD), a higher SCr, a low UO, and an intermediate [TIMP-2]*[IGFBP7] level; and subphenotype C was characterized by very low UO, a very high [TIMP-2]*[IGFBP7] level, and an intermediate SCr level. With subphenotype A as the reference, the adjusted hazard ratio (aHR) [95%CI] for the composite outcome was 3.77 [1.92-7.42] (p < 0.001) for subphenotype B and 4.80 [1.67-13.82] (p = 0.004) for subphenotype C. CONCLUSIONS: Combining conventional kidney function variables with urine measurements of [TIMP-2]*[IGFBP7] might help to identify distinct SA-AKI subphenotypes with different short-term courses and survival rates.
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Lesión Renal Aguda , Sepsis , Humanos , Mortalidad Hospitalaria , Estudios Prospectivos , Inhibidor Tisular de Metaloproteinasa-2 , Biomarcadores , Lesión Renal Aguda/etiología , Puntos de Control del Ciclo Celular , Sepsis/complicaciones , RiñónRESUMEN
OBJECTIVES: To describe early electrocardiogram (ECG) abnormalities after status epilepticus (SE) and evaluate their association with 90-day neurological outcomes. DESIGN: Retrospective analysis of a multicenter, national prospective registry between February 2018 and June 2020. SETTING: Sixteen ICUs in France, IctalGroup Research Network. PATIENTS: Adults with available ECG performed less than or equal to 24 hours after the onset of SE and less than or equal to 12 hours after its resolution. INTERVENTION: Double-blinded review of all ECGs was performed by two independent cardiologists. ECGs were categorized as normal/abnormal and then with minor/major early ECG abnormalities according to the Novacode ECG Classification system. MEASUREMENTS AND MAIN RESULTS: Among 155 critically ill patients with SE, early ECG abnormalities were encountered in 145 (93.5%), categorized as major in 91 of 145 (62.8%). In addition to sinus tachycardia, the main abnormalities were in the ST segment (elevation [16.6%] or depression [17.9%]) or negative T waves (42.1%). Major early ECG abnormalities were significantly associated with respiratory distress and sinus tachycardia at the scene and hyperlactatemia at ICU admission. By multivariable analysis, three variables were significantly associated with 90-day poor outcome: age, preexisting ultimately fatal comorbidity, and cerebral insult as the cause of SE. Early major ECG abnormalities were not independently associated with 90-day functional outcome. CONCLUSIONS: In our study, early ECG abnormalities in the acute phase of SE were frequent, often unrecognized and were associated with clinical and biological stigma of hypoxemia. Although they were not independently associated with 90-day functional outcome, ECG changes at the early stage of SE should be systematically evaluated. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03457831 .
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Estado Epiléptico , Taquicardia Sinusal , Adulto , Humanos , Estudios Retrospectivos , Arritmias Cardíacas , Hospitalización , ElectrocardiografíaRESUMEN
BACKGROUND: Intention-to-treat analyses of POINCARE-2 trial led to inconclusive results regarding the effect of a conservative fluid balance strategy on mortality in critically ill patients. The present as-treated analysis aimed to assess the effectiveness of actual exposure to POINCARE-2 strategy on 60-day mortality in critically ill patients. METHODS: POINCARE2 was a stepped wedge randomized controlled trial. Eligible patients were ≥ 18 years old, under mechanical ventilation and had an expected length of stay in ICU > 24 h. POINCARE-2 strategy consisted of daily weighing over 14 days, and subsequent restriction of fluid intake, administration of diuretics, and/or ultrafiltration. We computed a score of exposure to the strategy based on deviations from the strategy algorithm. We considered patients with a score ≥ 75 as exposed to the strategy. We used logistic regression adjusted for confounders (ALR) or for an instrumental variable (IVLR). We handled missing data using multiple imputations. RESULTS: A total of 1361 patients were included. Overall, 24.8% of patients in the control group and 69.4% of patients in the strategy group had a score of exposure ≥ 75. Exposure to the POINCARE-2 strategy was not associated with 60-day all-cause mortality (ALR: OR 1.2, 95% CI 0.85-1.55; IVLR: OR 1.0, 95% CI 0.76-1.33). CONCLUSION: Actual exposure to POINCARE-2 conservative strategy was not associated with reduced mortality in critically ill patients. Trial registration POINCARE-2 trial is registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.
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Enfermedad Crítica , Equilibrio Hidroelectrolítico , Adolescente , Humanos , Unidades de Cuidados Intensivos , AdultoRESUMEN
BACKGROUND: In critically ill patients, positive fluid balance is associated with excessive mortality. The POINCARE-2 trial aimed to assess the effectiveness of a fluid balance control strategy on mortality in critically ill patients. METHODS: POINCARE-2 was a stepped wedge cluster open-label randomized controlled trial. We recruited critically ill patients in twelve volunteering intensive care units from nine French hospitals. Eligible patients were ≥ 18 years old, under mechanical ventilation, admitted to one of the 12 recruiting units for > 48 and ≤ 72 h, and had an expected length of stay after inclusion > 24 h. Recruitment started on May 2016 and ended on May 2019. Of 10,272 patients screened, 1361 met the inclusion criteria and 1353 completed follow-up. The POINCARE-2 strategy consisted of a daily weight-driven restriction of fluid intake, diuretics administration, and ultrafiltration in case of renal replacement therapy between Day 2 and Day 14 after admission. The primary outcome was 60-day all-cause mortality. We considered intention-to-treat analyses in cluster-randomized analyses (CRA) and in randomized before-and-after analyses (RBAA). RESULTS: A total of 433 (643) patients in the strategy group and 472 (718) in the control group were included in the CRA (RBAA). In the CRA, mean (SD) age was 63.7 (14.1) versus 65.7 (14.3) years, and mean (SD) weight at admission was 78.5 (20.0) versus 79.4 (23.5) kg. A total of 129 (160) patients died in the strategy (control) group. Sixty-day mortality did not differ between groups [30.5%, 95% confidence interval (CI) 26.2-34.8 vs. 33.9%, 95% CI 29.6-38.2, p = 0.26]. Among safety outcomes, only hypernatremia was more frequent in the strategy group (5.3% vs. 2.3%, p = 0.01). The RBAA led to similar results. CONCLUSION: The POINCARE-2 conservative strategy did not reduce mortality in critically ill patients. However, due to open-label and stepped wedge design, intention-to-treat analyses might not reflect actual exposure to this strategy, and further analyses might be required before completely discarding it. Trial registration POINCARE-2 trial was registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.
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Enfermedad Crítica , Equilibrio Hidroelectrolítico , Humanos , Anciano , Adolescente , Enfermedad Crítica/terapia , Unidades de Cuidados Intensivos , Hospitalización , Respiración ArtificialRESUMEN
BACKGROUND: Previous literature on the determinants of diaphragm dysfunction in septic patients is limited. The goal of this study is to assess diaphragm dysfunction in terms of its prevalence and its potential associated factors in septic intensive care unit (ICU) patients. METHODS: This prospective and observational study was conducted between June 2015 and July 2019. Ultrasound measures of diaphragm thickness were performed daily on septic patients. The primary outcome was the prevalence of diaphragm dysfunction at baseline and during the ICU stay. The secondary outcome was the diaphragm thickness. Possible associated factors were prospectively recorded. RESULTS: Fifty patients were enrolled in the study. The prevalence of diaphragm dysfunction was 58%. No diaphragm atrophy was found during the ICU stay. Diaphragm dysfunction was associated with the alteration of consciousness, intra-abdominal sepsis, hypnotics and opioids, and mechanical ventilation. Administration of hypnotics, opioids, and steroids was associated with a decreased diaphragm thickening fraction. Diaphragm dysfunction had no impact on patient outcomes. CONCLUSIONS: Our data reveal a high prevalence of diaphragm dysfunction in septic patients at the onset of sepsis. Administration of hypnotics, opioids, and steroids was associated with the alteration of diaphragm function as well as intra-abdominal sepsis.
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Sepsis , Choque Séptico , Humanos , Choque Séptico/etiología , Estudios Prospectivos , Sepsis/etiología , Ultrasonografía , Estudios Longitudinales , Respiración Artificial/efectos adversos , Unidades de Cuidados IntensivosRESUMEN
BACKGROUND: The ageing of the population and the increased number of chronic diseases are associated with an increased frequency of end of life care in hospital settings. Residents rotating in hospital wards play a major part in their care, regardless of their specialty. General practitioner (GP) residents are confronted to such activities in hospital settings during their training. Our aim was to know how they feel about taking care of dying patients, as end-of-life care are very different from the clinical activity they are trained to. METHODS: We surveyed all GP trainees of "Ile de France". The survey was made of 41 questions regarding advanced directives divided in 7 sections about patients' care, communication, mentoring and repercussion on personal life. The survey was done one time, during two pre-specified days. RESULTS: 525 residents (53.8%) accepted to fulfill the survey. 74.1% of the residents thought that palliative care could have been better. Possible ways of improvements were: a reduction of unreasonable obstinacy (or therapeutic overkill, two terms defined in French law as curative treatment without reasonable hope of efficiency) (59.6%), patient's (210 answers, 40%) and relative's communication (information of patients and relatives about the severity of the disease and risk of death) (199 answers 37.9%). Residents also reported a lack of knowledge regarding end-of-life care specific treatments (411 answers, 79.3%) and 298 (47.2%) wished for better mentoring. Those difficulties were associated with repercussion on their private life (353 answers, 67.2%), particularly with their close relatives (55.4%). Finally, 56.2% of trainees thought that a systematic psychologic follow up should be instituted for those working in "at risk" hospital settings. CONCLUSION: Self-perception management of dying patients by GP resident emphasize their lack of training and supervision. The feeling of suboptimal care is associated with consequences on personal life.
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Médicos Generales , Cuidado Terminal , Humanos , Cuidados Paliativos , Directivas Anticipadas , ComunicaciónRESUMEN
BACKGROUND: Continuous electroencephalography (cEEG) is commonly recommended for neurocritical care patients. Routine implementation of such monitoring requires the specific training of professionals. The aim of this research was to evaluate the effectiveness of a training program on initiation of the basic interpretation of cEEG for critical care staff in a prospective multicenter study. METHODS: After completion of a pretest, participants (senior physicians, fellows, residents, medical students, and nurses) recruited in six French ICUs participated in a face-to-face electroencephalogram (EEG) training program followed by additional e-learning sessions at day 1 (post-course), day 15, day 30, and day 90, based on training tests followed by illustrated and commented answers. Each test was designed to evaluate knowledge and skills through correct recognition of ten predefined EEG sequences covering the most common normal and abnormal patterns. The primary objective was to achieve a success rate > 80% correct answers at day 90 by at least 75% of the participants. RESULTS: Among 250 participants, 77/108 (71.3%) who completed the full training program achieved at least 80% correct answers at day 90. Paired comparisons between the scores obtained at each evaluation showed an increase over time. The rate of correct answers at day 90 was > 80% for all common predefined EEG sequences, except for the recognition of periodic and burst-suppression patterns and reactivity, which were identified in only 42.6% (95% CI 36.4-48.8), 60.2% (54.1-66.3), and 70.4% (64.7-76.1) of the tests, respectively. CONCLUSIONS: A training strategy for the basic interpretation of EEG in ICUs, consisting of a face-to-face EEG course supplemented with reinforcement of knowledge by e-learning, was associated with significant resignation and an effectiveness of training allowing 71% of learners to accurately recognize important basic EEG patterns encountered in critically ill patients. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT03545776.
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Cuidados Críticos , Electroencefalografía , Humanos , Unidades de Cuidados Intensivos , Estudios ProspectivosRESUMEN
BACKGROUND: The urine biomarkers tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor-binding protein 7 (IGFBP7) have been validated for predicting and stratifying AKI. In this study, we analyzed the utility of these biomarkers for distinguishing between transient and persistent AKI in the early phase of septic shock. METHODS: We performed a prospective, multicenter study in 11 French ICUs. Patients presenting septic shock, with the development of AKI within the first 6 h, were included. Urine [TIMP-2]*[IGFBP7] was determined at inclusion (0 h), 6 h, 12 h, and 24 h. AKI was considered transient if it resolved within 3 days. Discriminative power was evaluated by receiver operating characteristic (ROC) curve analysis. RESULTS: We included 184 patients, within a median [IQR] time of 1.0 [0.0-3.0] h after norepinephrine (NE) initiation; 100 (54%) patients presented transient and 84 (46%) presented persistent AKI. Median [IQR] baseline urine [TIMP-2]*[IGFBP7] was higher in the persistent AKI group (2.21 [0.81-4.90] (ng/ml)2/1000) than in the transient AKI group (0.75 [0.20-2.12] (ng/ml)2/1000; p < 0.001). Baseline urine [TIMP-2]*[IGFBP7] was poorly discriminant, with an AUROC [95% CI] of 0.67 [0.59-0.73]. The clinical prediction model combining baseline serum creatinine concentration, baseline urine output, baseline NE dose, and baseline extrarenal SOFA performed well for the prediction of persistent AKI, with an AUROC [95% CI] of 0.81 [0.74-0.86]. The addition of urine [TIMP-2]*[IGFBP7] to this model did not improve the predictive performance. CONCLUSIONS: Urine [TIMP-2]*[IGFBP7] measurements in the early phase of septic shock discriminate poorly between transient and persistent AKI and do not improve clinical prediction over that achieved with the usual variables. TRIAL REGISTRATION: NCT02812784.
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Lesión Renal Aguda/diagnóstico , Biomarcadores/orina , Puntos de Control del Ciclo Celular/fisiología , Choque Séptico/complicaciones , Lesión Renal Aguda/complicaciones , Lesión Renal Aguda/fisiopatología , Área Bajo la Curva , Biomarcadores/análisis , Femenino , Francia , Humanos , Proteínas de Unión a Factor de Crecimiento Similar a la Insulina/análisis , Proteínas de Unión a Factor de Crecimiento Similar a la Insulina/orina , Unidades de Cuidados Intensivos/organización & administración , Unidades de Cuidados Intensivos/estadística & datos numéricos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROC , Choque Séptico/fisiopatología , Inhibidor Tisular de Metaloproteinasa-2/análisis , Inhibidor Tisular de Metaloproteinasa-2/orinaRESUMEN
An amendment to this paper has been published and can be accessed via the original article.
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BACKGROUND: The doctor-patient relationship has evolved to respect "the autonomy and patients' rights". One of the cornerstones in such autonomy is the opportunity for patients to draw living wills, also known as advance directives (AD). However, information about AD available to patients remains scarce largely due to the lack of involvement of General practitioners for several reasons. The aim of our study was to evaluate current general practitioner residents' (GPR) behavior concerning their role in informing their patients about AD. METHOD: We built a French nationwide survey from GPR class of 2012 to 2014. RESULTS: Two thousand three hundred ten residents completed our survey (21.1% of the total population of GPR during the period). 89.8% declared their willingness to offer patients the opportunity of writing AD. When asked about the usefulness of AD, 73.6% of residents responded that these are a suitable help for patients, but 19.7% considered that AD are essentially geared towards frail patients. Among residents who want to inform patients about AD (n = 2075), 14.7% wanted to involve all patients. Only 20.5% thought that elderly people should be systematically informed about AD. When the question involves other frail people in various disease areas, information seems relevant for 60.1% of GPR considering patient with cancer or malignant hematologic disease and for 56.2% about patients affected by neurodegenerative disease. When considering the routine use of AD, 20.5% of GPR would take them into account only if they are in agreement with the patient's decision. CONCLUSIONS: The results of the survey indicate that GPR would rather choose to decide who should be informed about AD, and when to take AD into account for ethical concerns.
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Directivas Anticipadas , Médicos Generales/ética , Derechos del Paciente/ética , Relaciones Médico-Paciente/ética , Directivas Anticipadas/ética , Actitud del Personal de Salud , Toma de Decisiones , Francia , Médicos Generales/psicología , Encuestas de Atención de la Salud , Humanos , Autonomía PersonalRESUMEN
IMPORTANCE: Norepinephrine, the first-line vasopressor for septic shock, is not always effective and has important catecholaminergic adverse effects. Selepressin, a selective vasopressin V1a receptor agonist, is a noncatecholaminergic vasopressor that may mitigate sepsis-induced vasodilatation, vascular leakage, and edema, with fewer adverse effects. OBJECTIVE: To test whether selepressin improves outcome in septic shock. DESIGN, SETTING, AND PARTICIPANTS: An adaptive phase 2b/3 randomized clinical trial comprising 2 parts that included adult patients (n = 868) with septic shock requiring more than 5 µg/min of norepinephrine. Part 1 used a Bayesian algorithm to adjust randomization probabilities to alternative selepressin dosing regimens and to trigger transition to part 2, which would compare the best-performing regimen with placebo. The trial was conducted between July 2015 and August 2017 in 63 hospitals in Belgium, Denmark, France, the Netherlands, and the United States, and follow-up was completed by May 2018. INTERVENTIONS: Random assignment to 1 of 3 dosing regimens of selepressin (starting infusion rates of 1.7, 2.5, and 3.5 ng/kg/min; n = 585) or to placebo (n = 283), all administered as continuous infusions titrated according to hemodynamic parameters. MAIN OUTCOMES AND MEASURES: Primary end point was ventilator- and vasopressor-free days within 30 days (deaths assigned zero days) of commencing study drug. Key secondary end points were 90-day mortality, kidney replacement therapy-free days, and ICU-free days. RESULTS: Among 868 randomized patients, 828 received study drug (mean age, 66.3 years; 341 [41.2%] women) and comprised the primary analysis cohort, of whom 562 received 1 of 3 selepressin regimens, 266 received placebo, and 817 (98.7%) completed the trial. The trial was stopped for futility at the end of part 1. Median study drug duration was 37.8 hours (IQR, 17.8-72.4). There were no significant differences in the primary end point (ventilator- and vasopressor-free days: 15.0 vs 14.5 in the selepressin and placebo groups; difference, 0.6 [95% CI, -1.3 to 2.4]; P = .30) or key secondary end points (90-day mortality, 40.6% vs 39.4%; difference, 1.1% [95% CI, -6.5% to 8.8%]; P = .77; kidney replacement therapy-free days: 18.5 vs 18.2; difference, 0.3 [95% CI, -2.1 to 2.6]; P = .85; ICU-free days: 12.6 vs 12.2; difference, 0.5 [95% CI, -1.2 to 2.2]; P = .41). Adverse event rates included cardiac arrhythmias (27.9% vs 25.2% of patients), cardiac ischemia (6.6% vs 5.6%), mesenteric ischemia (3.2% vs 2.6%), and peripheral ischemia (2.3% vs 2.3%). CONCLUSIONS AND RELEVANCE: Among patients with septic shock receiving norepinephrine, administration of selepressin, compared with placebo, did not result in improvement in vasopressor- and ventilator-free days within 30 days. Further research would be needed to evaluate the potential role of selepressin for other patient-centered outcomes in septic shock. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02508649.
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OBJECTIVES: Cardiac arrest is a catastrophic event that may arise during the management of convulsive status epilepticus. We aimed to report the clinical characteristics, outcomes, and early predictors of convulsive status epilepticus-related cardiac arrest. DESIGN: Retrospective multicenter study. SETTING: Seventeen university or university affiliated participating ICUs in France and Belgium. PATIENTS: Consecutive patients admitted to the participating ICUs for management of successfully resuscitated out-of-hospital cardiac arrest complicating the initial management of convulsive status epilepticus between 2000 and 2015. Patients were compared with controls without cardiac arrest identified in a single-center registry of convulsive status epilepticus patients, regarding characteristics, management, and outcome. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We included 49 cases with convulsive status epilepticus-cardiac arrest and 235 controls. In the cases, median time from medical team arrival to cardiac arrest was 25 minutes (interquartile range, 5-85 min). First recorded rhythm was asystole in 25 patients (51%) and pulseless electrical activity in 13 patients (27%). A significantly larger proportion of patients had a favorable 1-year outcome (Glasgow Outcome Scale score of 5) among controls (90/235; 38%) than among cases (10/49; 21%; p = 0.02). By multivariate analysis, independent predictors of cardiac arrest were pulse oximetry less than 97% on scene (odds ratio, 2.66; 95% CI, 1.03-7.26; p = 0.04), drug poisoning as the cause of convulsive status epilepticus (odds ratio, 4.13; 95% CI, 1.27-13.53; p = 0.02), and complications during early management (odds ratio, 11.98; 95% CI, 4.67-34.69; p < 0.0001). Having at least one comorbidity among cardiac, respiratory, and neurologic (other than epilepsy) conditions predicted absence of cardiac arrest (odds ratio, 0.28; 95% CI, 0.10-0.80; p = 0.02). CONCLUSIONS: In patients managed for convulsive status epilepticus, relative hypoxemia, on-scene management complications, and drug poisoning as the cause of convulsive status epilepticus were strong early predictors of cardiac arrest, suggesting areas for improvement.
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Paro Cardíaco/epidemiología , Paro Cardíaco/terapia , Estado Epiléptico/epidemiología , Estado Epiléptico/terapia , Adulto , Anciano , Reanimación Cardiopulmonar , Enfermedades Cardiovasculares/epidemiología , Comorbilidad , Electroencefalografía , Femenino , Humanos , Hipoxia/epidemiología , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Enfermedades del Sistema Nervioso/epidemiología , Respiración Artificial/métodos , Enfermedades Respiratorias/epidemiología , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Vasoconstrictores/administración & dosificaciónRESUMEN
OBJECTIVES: To investigate family perceptions of having a nurse participating in family conferences and to assess the psychologic well being of the same families after ICU discharge. DESIGN: Mixed-method design with a qualitative study embedded in a single-center randomized study. SETTING: Twelve-bed medical-surgical ICU in a 460-bed tertiary hospital. SUBJECTS: One family member for each consecutive patient who received more than 48 hours of mechanical ventilation in the ICU. INTERVENTION: Planned proactive participation of a nurse in family conferences led by a physician. In the control group, conferences were led by a physician without a nurse. MEASUREMENTS AND MAIN RESULTS: Of the 172 eligible family members, 100 (60.2%) were randomized; among them, 88 underwent semistructured interviews at ICU discharge and 86 completed the Peritraumatic Dissociative Experiences Questionnaire at ICU discharge and then the Hospital Anxiety Depression Questionnaire and the Impact of Event Scale (for posttraumatic stress-related symptoms) 3 months later. The intervention and control groups were not significantly different regarding the prevalence of posttraumatic stress-related symptoms (52.3 vs 50%, respectively; p = 0.83). Anxiety and depression subscale scores were significantly lower in the intervention group. The qualitative data indicated that the families valued the principle of the conference itself. Perceptions of nurse participation clustered into four main themes: trust that ICU teamwork was effective (50/88; 56.8%), trust that care was centered on the patient (33/88; 37.5%), trust in effective dissemination of information (15/88; 17%), and trust that every effort was made to relieve anxiety in family members (12/88; 13.6%). CONCLUSIONS: Families valued the conferences themselves and valued the proactive participation of a nurse. These positive perceptions were associated with significant anxiety or depression subscale scores but not with changes in posttraumatic stress-related symptoms.
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Familia/psicología , Unidades de Cuidados Intensivos , Rol de la Enfermera , Rol del Médico , Relaciones Profesional-Familia , Trastornos por Estrés Postraumático/epidemiología , Anciano , Ansiedad/epidemiología , Comunicación , Depresión/epidemiología , Femenino , Procesos de Grupo , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Grupo de Atención al Paciente , Prevalencia , Escalas de Valoración Psiquiátrica , Encuestas y Cuestionarios , ConfianzaRESUMEN
PURPOSE: This study aimed to evaluate the impact on subsequent infections and mortality of an adequate antimicrobial therapy within 48 h after catheter removal in intensive care unit (ICU) patients with positive catheter tip culture. METHODS: We performed a retrospective analysis of prospectively collected data from 29 centers of the OUTCOMEREA network. We developed a propensity score (PS) for adequate antimicrobial treatment, based on expert opinion of 45 attending physicians. We conducted a 1:1 case-cohort study matched on the PS score of being adequately treated. A PS-matched subdistribution hazard model was used for detecting subsequent infections and a PS-matched Cox model was used to evaluate the impact of antibiotic therapy on mortality. RESULTS: We included 427 patients with a catheter tip culture positive with potentially pathogenic microorganisms. We matched 150 patients with an adequate antimicrobial therapy with 150 controls. In the matched population, 30 (10%) subsequent infections were observed and 62 patients died within 30 days. Using subdistribution hazard models, the daily risk to develop subsequent infection up to Day-30 was similar between treated and non-treated groups (subdistribution hazard ratio [sHR] 1.08, 95% confidence interval [CI] 0.62-1.89, p = 0.78). Using Cox proportional hazard models, the 30-day mortality risk was similar between treated and non-treated groups (HR 0.89, 95% CI 0.45-1.74, p = 0.73). CONCLUSIONS: Antimicrobial therapy was not associated with decreased risk of subsequent infection or death in short-term catheter tip colonization in critically ill patients. Antibiotics may be unnecessary for positive catheter tip cultures.
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Infecciones Relacionadas con Catéteres , Enfermedad Crítica , Unidades de Cuidados Intensivos , Humanos , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Infecciones Relacionadas con Catéteres/tratamiento farmacológico , Infecciones Relacionadas con Catéteres/microbiología , Infecciones Relacionadas con Catéteres/mortalidad , Anciano , Unidades de Cuidados Intensivos/estadística & datos numéricos , Estudios de Casos y Controles , Modelos de Riesgos Proporcionales , Antibacterianos/uso terapéutico , Puntaje de Propensión , Estudios de CohortesRESUMEN
AIM: To investigate the performance of the 2021 ERC/ESICM-recommended algorithm for predicting poor outcome after cardiac arrest (CA) and potential tools for predicting neurological recovery in patients with indeterminate outcome. METHODS: Prospective, multicenter study on out-of-hospital CA survivors from 28 ICUs of the AfterROSC network. In patients comatose with a Glasgow Coma Scale motor score ≤3 at ≥72 h after resuscitation, we measured: (1) the accuracy of neurological examination, biomarkers (neuron-specific enolase, NSE), electrophysiology (EEG and SSEP) and neuroimaging (brain CT and MRI) for predicting poor outcome (modified Rankin scale score ≥4 at 90 days), and (2) the ability of low or decreasing NSE levels and benign EEG to predict good outcome in patients whose prognosis remained indeterminate. RESULTS: Among 337 included patients, the ERC-ESICM algorithm predicted poor neurological outcome in 175 patients, and the positive predictive value for an unfavourable outcome was 100% [98-100]%. The specificity of individual predictors ranged from 90% for EEG to 100% for clinical examination and SSEP. Among the remaining 162 patients with indeterminate outcome, a combination of 2 favourable signs predicted good outcome with 99[96-100]% specificity and 23[11-38]% sensitivity. CONCLUSION: All comatose resuscitated patients who fulfilled the ERC-ESICM criteria for poor outcome after CA had poor outcome at three months, even if a self-fulfilling prophecy cannot be completely excluded. In patients with indeterminate outcome (half of the population), favourable signs predicted neurological recovery, reducing prognostic uncertainty.
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BACKGROUND: Cardiogenic shock (CS) is the most severe form of acute heart failure. Discrepancies have been reported between sexes regarding delays, pathways and invasive strategies in CS complicating acute myocardial infarction. However, effect of sex on the prognosis of unselected CS remains controversial. OBJECTIVES: The aim was to analyze the impact of sex on aetiology, management and prognosis of CS. METHODS: The FRENSHOCK registry included all CS admitted in 49 French Intensive Care Units (ICU) and Intensive Cardiac Care Units (ICCU) between April and October 2016. RESULTS: Among the 772 CS patients included, 220 were women (28.5%). Women were older, less smokers, with less history of ischemic cardiac disease (20.5% vs 33.6%) than men. At admission, women presented less cardiac arrest (5.5 vs 12.2%), less mottling (32.5 vs 41.4%) and higher LVEF (30 ± 14 vs 25 ± 13%). Women were more often managed via emergency department while men were directly admitted at ICU/ICCU. Ischemia was the most frequent trigger irrespective of sex (36.4% in women vs 38.2%) but women had less coronary angiogram and PCI (45.9% vs 54% and 24.1 vs 31.3%, respectively). We found no major difference in medication and organ support. Thirty-day mortality (26.4 vs 26.5%), transplant or permanent assist device were similar in both sexes. CONCLUSION: Despite some more favorable parameters in initial presentation and no significant difference in medication and support, women shared similar poor prognosis than men. Further analysis is required to cover the lasting gap in knowledge regarding sex specificities to distinguish between differences and inequalities. NCT02703038.
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Sistema de Registros , Choque Cardiogénico , Humanos , Choque Cardiogénico/terapia , Choque Cardiogénico/mortalidad , Choque Cardiogénico/epidemiología , Femenino , Masculino , Anciano , Factores Sexuales , Francia/epidemiología , Persona de Mediana Edad , Unidades de Cuidados Intensivos/estadística & datos numéricos , PronósticoRESUMEN
INTRODUCTION: Studies have reported associations between diaries kept for intensive care unit (ICU) patients and long-term quality-of-life and psychological outcomes in patients and their relatives. Little was known about perceptions of healthcare workers reading and writing in the diaries. We investigated healthcare worker perceptions the better to understand their opinions and responses to reading and writing in the diaries. METHODS: We used a phenomenologic approach to conduct a qualitative study of 36 semistructured interviews in a medical-surgical ICU in a 460-bed tertiary hospital. RESULTS: Two domains of perception were assessed: reading and writing in the diaries. These two domains led to four main themes in the ICU workers' perceptions: suffering of the families; using the diary as a source of information for families but also as generating difficulties in writing bad news; determining the optimal interpersonal distance with the patient and relatives; and using the diary as a tool for constructing a narrative of the patient's ICU stay. CONCLUSIONS: The ICU workers thought that the diary was beneficial in communicating the suffering of families while providing comfort and helping to build the patient's ICU narrative. They reported strong emotions related to the diaries and a perception of intruding into the patients' and families' privacy when reading the diaries. Fear of strong emotional investment may adversely affect the ability of ICU workers to perform their duties optimally. ICU workers are in favor of ICU diaries, but activation by the diaries of emotions among younger ICU workers may require specific support.
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Actitud del Personal de Salud , Cuidados Críticos/psicología , Unidades de Cuidados Intensivos , Registros Médicos , Estadística como Asunto , Adulto , Cuidados Críticos/métodos , Femenino , Humanos , Masculino , Estadística como Asunto/métodosRESUMEN
IMPORTANCE: Despite advances in care, mortality and morbidity remain high in adults with acute bacterial meningitis, particularly when due to Streptococcus pneumoniae. Induced hypothermia is beneficial in other conditions with global cerebral hypoxia. OBJECTIVE: To test the hypothesis that induced hypothermia improves outcome in patients with severe bacterial meningitis. DESIGN, SETTING, AND PATIENTS: An open-label, multicenter, randomized clinical trial in 49 intensive care units in France, February 2009-November 2011. In total, 130 patients were assessed for eligibility and 98 comatose adults (Glasgow Coma Scale [GCS] score of ≤8 for <12 hours) with community-acquired bacterial meningitis were randomized. INTERVENTIONS: Hypothermia group received a loading dose of 4°C cold saline and were cooled to 32°C to 34°C for 48 hours. The rewarming phase was passive. Controls received standard care. MAIN OUTCOMES AND MEASURES: Primary outcome measure was the Glasgow Outcome Scale score at 3 months (a score of 5 [favorable outcome] vs a score of 1-4 [unfavorable outcome]). All patients received appropriate antimicrobial therapy and vital support. Analyses were performed on an intention-to-treat basis. The data and safety monitoring board (DSMB) reviewed severe adverse events and mortality rate every 50 enrolled patients. RESULTS: After inclusion of 98 comatose patients, the trial was stopped early at the request of the DSMB because of concerns over excess mortality in the hypothermia group (25 of 49 patients [51%]) vs the control group (15 of 49 patients [31%]; relative risk [RR], 1.99; 95% CI, 1.05-3.77; P = .04). Pneumococcal meningitis was diagnosed in 77% of patients. Mean (SD) temperatures achieved 24 hours after randomization were 33.3°C (0.9°C) and 37.0°C (0.9°C) in the hypothermia and control group, respectively. At 3 months, 86% in the hypothermia group compared with 74% of controls had an unfavorable outcome (RR, 2.17; 95% CI, 0.78-6.01; P = .13). After adjustment for age, score on GCS at inclusion, and the presence of septic shock at inclusion, mortality remained higher, although not significantly, in the hypothermia group (hazard ratio, 1.76; 95% CI, 0.89-3.45; P = .10). Subgroup analysis on patients with pneumococcal meningitis showed similar results. Post hoc analysis showed a low probability to reach statistically significant difference in favor of hypothermia at the end of the 3 planned sequential analyses (probability to conclude in favor of futility, 0.977). CONCLUSIONS AND RELEVANCE: Moderate hypothermia did not improve outcome in patients with severe bacterial meningitis and may even be harmful. Careful evaluation of safety issues in future trials on hypothermia are needed and may have important implications in patients presenting with septic shock or stroke. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00774631.
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Coma , Hipotermia Inducida/efectos adversos , Meningitis Neumocócica/terapia , Adulto , Anciano , Antibacterianos/uso terapéutico , Temperatura Corporal , Terminación Anticipada de los Ensayos Clínicos , Femenino , Escala de Coma de Glasgow , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: The optimal first-line noninvasive respiratory support (NIRS) to improve outcome in patients affected by COVID-19 pneumonia admitted to ICU is still debated. METHODS: We conducted a retrospective study in seven French ICUs, including all adults admitted between July and December 2020 with documented SARS-CoV-2 acute respiratory failure (PaO2/FiO2<300 mmHg), and treated with either high-flow nasal therapy (HFNT) alone, noninvasive ventilation alone or in combination with HFNT (NIV), or continuous positive airway pressure alone or in combination with HFNT (CPAP). The primary outcome was NIRS failure at day 28, defined as the need for endotracheal intubation (ETI) or death without ETI. RESULTS: Among the 355 patients included, 160 (45%) were treated with HFNT alone, 115 (32%) with NIV and 80 (23%) with CPAP. The primary outcome occurred in 65 (41%), 69 (60%), and 25 (31%) patients among those treated with HFNT alone, NIV, and CPAP, respectively (P<0.001). After univariate analysis, patients treated with CPAP had a trend for a lower incidence of the primary outcome, whereas patients treated with NIV had a significant higher incidence of the primary outcome, both compared to those treated with HFNT alone (unadjusted Hazard ratio 0.67; 95% CI [0.42-1.06], and 1.58; 95% CI [1.12-2.22]; P=0.09 and 0.008, respectively). CONCLUSIONS: Among ICU patients admitted for severe COVID-19 pneumonia and managed with NIRS, the outcome seems to differ according to the initial chosen strategy. Prospective randomized controlled studies are warranted to identify the optimal strategy.