ABSTRACT
INTRODUCTION: Expanded-criteria donors (ECDs) are used to reduce the shortage of kidneys for transplantation. However, kidneys from ECDs are associated with an increased risk of delayed graft function (DGF), a risk factor for allograft loss and mortality. HYPOREME will be a multicentre randomised controlled trial (RCT) comparing targeted hypothermia to normothermia in ECDs, in a country where the use of machine perfusion for organ storage is the standard of care. We hypothesise that hypothermia will decrease the incidence of DGF. METHODS AND ANALYSIS: HYPOREME is a multicentre RCT comparing the effect on kidney function in recipients of targeted hypothermia (34°C-35°C) and normothermia (36.5°C-37.5°C) in the ECDs. The temperature intervention starts from randomisation and is maintained until aortic clamping in the operating room. We aim to enrol 289 ECDs in order to analyse the kidney function of 516 recipients in the 53 participating centres. The primary outcome is the occurrence of DGF in kidney recipients, defined as a requirement for renal replacement therapy within 7 days after transplantation (not counting a single session for hyperkalemia during the first 24 hours). Secondary outcomes include the proportion of patients with individual organs transplanted in each group; the number of organs transplanted from each ECD and the vital status and kidney function of the recipients 7 days, 28 days, 3 months and 1 year after transplantation. An interim analysis is planned after the enrolment of 258 kidney recipients. ETHICS AND DISSEMINATION: The trial was approved by the ethics committee of the French Intensive Care Society (CE-SRLF-16-07) on 26 April 2016 and by the competent French authorities on 20 April 2016 (Comité de Protection des Personnes-TOURS-Région Centre-Ouest 1, registration #2016-S3). Findings will be published in peer-reviewed journals and presented during national and international scientific meetings. TRIAL REGISTRATION NUMBER: NCT03098706.
Subject(s)
Hypothermia , Kidney Transplantation , Transplants , Graft Survival , Humans , Hypothermia/etiology , Kidney , Kidney Transplantation/adverse effects , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Tissue DonorsABSTRACT
CONTEXT: In ICUs, many patients are intubated. UE is an indicator of the quality of care.Isolation associated with "air" precautions may increase the number of UEs in mechanically ventilated (MV) COVID patients.The main aim of the study was to compare the rate of UE between a COVID-19 period and a control period. The secondary aims were to identify UE risk factors and to study the experience of caregivers during the COVID-19 period. METHOD: The method of choice was a retrospective single center case-control study. MV patients aged ≥ 18 years were eligible in two periods: the control period from 01/02/2020 to 29/02/2020, and the COVID-19 period from 01/03/2020 to 31/03/2020. An anonymous survey was given to ICU caregivers in Vannes Hospital. RESULTS: The UE rate was 17% (n=7) vs. 20% (n=9) control period vs. COVID-19 period (p=0.58), with nocturnal preponderance (75%). A quarter (n=4) of patients fulfill MV weaning criteria at the time of UE. A 71% (n=49) survey response rate was obtained. The COVID-19 period had a higher estimated UE risk for 76% (n=37) of caregivers, who felt that they had a greater workload, difficulties with monitoring, and decreased regular visits to patients' rooms. CONCLUSION: Contrary to the caregiver experience, we reported a similar UE rate over both the COVID-19 period and the control period.
Subject(s)
Airway Extubation , COVID-19 , Airway Extubation/adverse effects , COVID-19/epidemiology , Case-Control Studies , Critical Care/methods , Humans , Pandemics , Respiration, Artificial , Retrospective StudiesABSTRACT
CONTEXT: In ICUs, many patients are intubated. UE is an indicator of the quality of care.Isolation associated with "air" precautions may increase the number of UEs in mechanically ventilated (MV) COVID patients.The main aim of the study was to compare the rate of UE between a COVID-19 period and a control period. The secondary aims were to identify UE risk factors and to study the experience of caregivers during the COVID-19 period. METHOD: The method of choice was a retrospective single center case-control study. MV patients aged ≥ 18 years were eligible in two periods: the control period from 01/02/2020 to 29/02/2020, and the COVID-19 period from 01/03/2020 to 31/03/2020. An anonymous survey was given to ICU caregivers in Vannes Hospital. RESULTS: The UE rate was 17% (n=7) vs. 20% (n=9) control period vs. COVID-19 period (p=0.58), with nocturnal preponderance (75%). A quarter (n=4) of patients fulfill MV weaning criteria at the time of UE. A 71% (n=49) survey response rate was obtained. The COVID-19 period had a higher estimated UE risk for 76% (n=37) of caregivers, who felt that they had a greater workload, difficulties with monitoring, and decreased regular visits to patients' rooms. CONCLUSION: Contrary to the caregiver experience, we reported a similar UE rate over both the COVID-19 period and the control period.
Subject(s)
Airway Extubation , COVID-19 , Airway Extubation/adverse effects , COVID-19/epidemiology , Case-Control Studies , Humans , Intensive Care Units , Pandemics , Respiration, Artificial , Retrospective StudiesABSTRACT
BACKGROUND: Despite few studies, a monitoring of a neuromuscular blockade with a train of four (TOF) is recommended in intensive care unit (ICU). Our objective was to compare the results of ulnar and facial TOF measurements with an overall clinical assessment for neuromuscular blockade in ICU patients treated with recommended doses of atracurium or cisatracurium, including patients with acute respiratory disease syndrome (ARDS). METHODS: We prospectively included in two ICUs 119 patients, 94 with ARDS, who required a neuromuscular blockade for more than 24 h. Three levels of neuromuscular blockade were defined: "over-paralyzed" (TOF = 0), "well-paralyzed" (TOF = 1-2), and "under-paralyzed" (TOF = 3-4). Physicians blinded for TOF counts were asked to classify patients clinically as "over-paralyzed," "well-paralyzed," or "under-paralyzed". Patients were assessed two times daily. RESULTS: For the whole population 996 ulnar and facial TOF measurements and clinical assessments were obtained (846 with cisatracurium and 150 with atracurium). Proportions of patients classified as over-paralyzed, well-paralyzed, and under-paralyzed based on TOF measurements and clinical assessments differed significantly (p < 0.0001). The number of observed agreements between clinical assessments and facial TOF measurements was of 19.08% (κ = 0.06) and of 17.37% with ulnar TOF measurements (κ = 0.04), while it was of 62.75% between ulnar and facial TOF measurements (κ = 0.45). Results were similar for cisatracurium and atracurium. Repeated facial TOF measurements performed on the first 4 days of mechanical ventilation in ARDS patients showed that the proportion of patients TOF = 1-2 was around 8% and did not vary significantly with time (p = 0.9), proportion of patients TOF = 3-4 increased from 24 to 40% (p = 0.01), proportion of patients TOF = 0 decreased from 71 to 53% (p = 0.005) while objectives for protective ventilation were achieved. Proportions of facial and ulnar TOF = 0 were significantly higher among patients with ICU-acquired weakness (ICU-AW) versus those who did not develop ICU-AW (51 vs. 40%, p = 0.03, and 76 vs. 62%, p = 0.006, respectively). CONCLUSIONS: The study provides data on clinical and TOF monitoring of neuromuscular blockade, which are widely divergent in ICU patients receiving recommended doses of benzylisoquinoliniums.
