Neurological Criteria Research Articles

Developing and Expanding Deceased Organ Donation to its Maximum Therapeutic Potential: An Actionable Global Challenge From the 2023 Santander Summit.

On November 9 and 10, 2023, the Organización Nacional de Trasplantes (ONT), under the Spanish Presidency of the Council of the European Union, convened in Santander a Global Summit entitled "Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight." This article summarizes two distinct but related challenges elaborated at the Santander Summit by Working Group 2 that must be overcome if we are to develop and expand deceased donation worldwide and achieve the goal of self-sufficiency in organ donation and transplantation. Challenge 1: the need for a unified concept of death based on the permanent cessation of brain function. Working group 2 proposed that challenge 1 requires the global community to work toward a uniform, worldwide definition of human death, conceptually unifying circulatory and neurological criteria of death around the cessation of brain function and accepting that permanent cessation of brain function is a valid criterion to determine death. Challenge 2: reducing disparities in deceased donation and increasing organ utilization through donation after the circulatory determination of death (DCDD). Working group 2 proposed that challenge 2 requires the global community to work toward increasing organ utilization through DCDD, expanding DCDD through in situ normothermic regional perfusion, and expanding DCDD through ex situ machine organ perfusion technology. Recommendations for implementation are described.

The role of the United Kingdom national poisons information service (NPIS) in the diagnosis of death according to neurological criteria in poisoned and non-poisoned patients.

The diagnosis of death by neurological criteria (DNC) requires the exclusion of any clinical effect attributable to xenobiotics. We undertook a retrospective analysis of enquiries to the National Poisons Information Service (NPIS) relating to DNC over a 10-year period. Enquiries were categorised as toxicological, where exposure to a non-therapeutically administered xenobiotic was implicated in the clinical presentation and non-toxicological where exposure to the xenobiotic was not the primary cause of the clinical state. The frequency of enquiry to the NPIS regarding xenobiotics and DNC demonstrates that it remains a valuable source of expert advice.

Requesting Relatives' Consent for Intensive Care for Organ Donation: An Empirical Analysis of Spanish Transplant Coordinators' Practices.

Intensive care to facilitate organ donation (ICOD) involves the initiation or continuation of intensive care for patients with devastating brain injury for donation purposes. In the Spanish system, relatives undergo an early interview to request consent for this procedure. If they consent, a waiting time is agreed upon in the expectation that death by neurological criteria occurs and donation after brain death takes place. Otherwise, relatives can decide on donation after circulatory determination of death or withdrawal of life support. This study analyzes how Spanish transplant coordinators interact with relatives in early interviews and follow-ups on potential donation pathways. Semistructured interviews were conducted with a random stratified sample of 23 Spanish transplant coordination teams to explore strategies, practices, and perceptions of ICOD consent requests. The interviews were recorded, transcribed, and analyzed using content analysis. Previous coordination with other units and information retrieval regarding patient and relatives' situations is crucial. The development of early interviews includes an introduction to the family, identification of decision makers, empathizing with relatives and offering condolences, reaffirming the fatal prognosis, explaining the possibility of donating based on the patient's will, confirming the family's understanding and resolving doubts, and ensuring comfort and assessing family needs. Approaching families to obtain ICOD consent is a regular practice for Spanish coordination teams. It involves a highly professional and diversified set of strategies based on establishing a support relationship for relatives. Our study provides strategies that serve as a reference for obtaining ICOD consent from families in other settings.

6394 Prevalence of Diabetes Insipidus in Pediatric Patients Who Have Been Declared Dead by Neurologic Criteria

Abstract Disclosure: C.E. Larancuent: None. V. Merilan: None. M. Leoncio: None. J.M. Lozano: None. B.R. Totapally: None. Introduction: Death by neurological criteria (DNC) or brain death (BD), occurs in individuals who have sustained catastrophic brain injury and are in permanent coma with loss of all brainstem function, coupled with the inability to breathe in the setting of hypercarbia and acidosis. Diabetes insipidus (DI) occurs in many but not all patients with DNC. Several studies indicate varying prevalence rates of DI among pediatric patients with DNC. Objective: Our objective was to determine the prevalence of DI in children who have been declared DNC, and the frequency of DI in these children according to the mechanism of brain injury. Methods: A retrospective analysis of 57 pediatric inpatients 0-21 years subsequently declared BD at Nicklaus Children’s Hospital from January 2013 to June 2023. Data was gathered from the hospital's electronic medical records and the VPS database. The primary exposure is brain death, while the secondary exposure is the mechanism of brain injury. These injuries were categorized into anoxic, traumatic brain injury (TBI), and brain tumors/space-occupying lesions (malignancy). The prevalence of DI was assessed as the primary outcome, and it was compared between three etiologies for brain death using Pearson Chi-square. Due to the study's small sample size, the association between the cause of BD and DI was not adjusted by covariates, such as sex and age. This study was exempted by the IRB. Results: Of the 53 patients declared BD, 47 (88.7%, 95% CI 77.9% to 95.3%) were diagnosed with DI. The prevalence of DI did not change significantly according to the etiology of brain injury leading to BD (84.4%, 100.0%, and 92.3% for anoxic brain injury, TBI, and malignancy, respectively; p = 0.410). The characteristics of children according to the etiology of brain death are presented in Table 1. The characteristics of children according to the development of DI are presented in Table 2. ICU length of stay, the duration to brain death declaration, and eligibility for organ donation varied with the etiology of brain death (Table 1). Conclusions: The prevalence of DI is high in pediatric patients declared BD, and it is not significantly different based on the etiology of brain death. Given this high prevalence, diligent DI management is needed to improve organ donation outcomes. Presentation: 6/2/2024

Predictive Hypoxemic Threshold for Tolerating the Apnea Test While Assessing Death by Neurological Criteria

Abstract Background The apnea test (AT) plays a vital role in diagnosing brain death by evaluating the absence of spontaneous respiratory activity. It entails disconnecting the patient from mechanical ventilation to raise the CO2 partial pressure and lower the pH. Occasionally, the AT is aborted because of safety concerns, such as hypoxemia and hemodynamic instability, to prevent worsening conditions. However, the exact oxygen partial pressure level needed before commencing AT, indicating an inability to tolerate the test, is still uncertain. This study seeks to determine pre-AT oxygen levels linked with a heightened risk of test failure. Methods We conducted a retrospective cohort study involving patients suspected of having brain death at the Tel Aviv Medical Center from 2010 to 2022. The primary outcome was defined as an arterial partial O2 pressure (PaO2) level of 60 mmHg or lower at the conclusion of the AT. This threshold is significant because it marks the point at which the saturation curve deflects, potentially leading to rapid deterioration in the patient’s oxygen saturation. Results Among the 70 patients who underwent AT, 7 patients met the primary diagnostic criteria. Patients with a PaO2 ≤ 60 mmHg at the conclusion of the AT exhibited a significantly lower initial median PaO2 of 243.7 mmHg compared with those with higher pre-AT PaO2 levels of 374.8 mmHg (interquartile range 104.65–307.00 and interquartile range 267.8–444.9 respectively, P value = 0.0041). Pre-AT PaO2 levels demonstrated good discriminatory ability for low PaO2 levels according to the receiver operating characteristic (ROC) curve, with an area under the curve of 0.76 (95% confidence interval 0.52–0.99). Conclusions PaO2 values at the conclusion of the AT are closely associated with PaO2 values at the beginning of the test. Establishing a cutoff value of approximately 300 mmHg PaO2 at the onset of AT may assist in avoiding saturation drops below 90%.

SIGNET: protocol for a multicentre, single-blind prospective, group sequential, randomised controlled trial to evaluate the benefits of a single dose of simvastatin given to potential organ donors declared dead by neurological criteria on outcomes in organ recipients

IntroductionSuccessful organ transplantation in patients with end-stage organ failure improves long-term survival, improves quality of life and reduces costs to the NHS. Despite an increase in the number of deceased...

Enhancing maternal survival in traumatic cardiovascular collapse during pregnancy: A case series on resuscitative hysterotomy (RH) from a level 1 trauma center

Background: Trauma during pregnancy presents multifaceted risks to both the developing fetus and the expectant mother due to pregnancy-induced physiological adaptations that affect the response to traumatic injuries. The infrequent occurrence of cardiac arrest during pregnancy necessitates interventions such as perimortem cesarean section (PMCS), now termed resuscitative hysterotomy. While early resuscitative hysterotomy focused primarily on fetal survival, more recent literature reports substantial maternal benefits. Resuscitative hysterotomy can lead to the restoration of maternal pulse and blood pressure within minutes and has shown potential to improve maternal outcomes. RH has been demonstrated to aid in fetal and maternal survival in hemodynamic unstable pregnant patients before cardiovascular collapse. The linguistic change from PMCS to resuscitative hysterotomy is a shift towards maternal-centric approaches and survival. ObjectiveIn this series, we evaluate the outcomes of resuscitative hysterotomy performed before or after cardiovascular collapse to maximize maternal survival while concurrently optimizing fetal outcomes. MethodsWe performed a retrospective case series review of 4 consecutive pregnant trauma patients who underwent RH due to hemodynamic instability. In addition, we conducted a descriptive analysis of all pregnant patients from 2013 to May 2024 who presented due to a traumatic injury but did not require a RH. ResultsThe average age of patients undergoing RH was 26.5 ± 6.8 years. All patients were in the third trimester with a mean gestational age of 32.3 ± 0.5 weeks. Fifty percent (50 %) of patients were involved in motor vehicle accidents, one (25 %) pedestrian was hit by a vehicle, and one (25 %) had GSW to the head. The median time to RH was 14.5 min. The mean estimated blood loss (EBL) was 625 mL ±108.9 mL. The maternal survival rate was 50 %, with a fetal survival rate of 100 %. Three patients achieved hemodynamic stability; however, one of the patients progressed to death by neurological criteria. Therefore, we achieved 50 % of maternal survival. A resuscitative hysterotomy was performed due to early signs of maternal hemorrhagic shock and suggestive features of ongoing bleeding (persistent maternal tachycardia despite adequate analgesia and resuscitation, persistent maternal bradycardia, gradual decline of BP, and FHR abnormalities) in three patients. The remaining patient was found to have cardiac arrest at the scene with a brief return of spontaneous circulation and received resuscitative hysterotomy in the ED to restore cardiovascular function. ConclusionRH in pregnant patients with traumatic injury and impending hemorrhagic shock or cardiovascular collapse may provide maternal survival benefits by supporting circulatory function and promoting resuscitation with no additional risks to fetal outcomes. Quick decision-making is crucial to the implementation of this life-saving procedure. Further research with a more significant number of patients is needed to validate the efficacy of RH in maximizing maternal survival. This case series adds to the evolving literature on RH, shedding light on practical aspects and maternal outcomes to inform ongoing discussions and strategies for maternal cardiopulmonary resuscitation.

Research involving the recently deceased: ethics questions that must be answered

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria—or ‘research involving the recently deceased’—can fill a translational research gap while reducing harm to...

Defining Death: Toward a Biological and Ethical Synthesis

Much of the debate over the definition and criteria for determining our death has focused on disagreement over the correct biological account of death, i.e., what it means for any organism to die. In this paper, we argue that this exclusive focus on the biology of death is misguided, because it ignores ethical and social factors that bear on the acceptability of criteria for determining our death. We propose that attention shift from strictly biological considerations to ethical and social considerations that bear on the determination of what we call “civil death.” We argue for acceptance of a neurological criterion for determining death on grounds that it is the most reasonable way to synthesize biological, ethical, and social considerations about our death..

Author Response: Pediatric and Adult Brain Death/Death by Neurologic Criteria Consensus Guideline: Report of the AAN Guidelines Subcommittee, AAP, CNS, and SCCM.

Author Response: Pediatric and Adult Brain Death/Death by Neurologic Criteria Consensus Guideline: Report of the AAN Guidelines Subcommittee, AAP, CNS, and SCCM.

Author Response: Pediatric and Adult Brain Death/Death by Neurologic Criteria Consensus Guideline: Report of the AAN Guidelines Subcommittee, AAP, CNS, and SCCM.

Author Response: Pediatric and Adult Brain Death/Death by Neurologic Criteria Consensus Guideline: Report of the AAN Guidelines Subcommittee, AAP, CNS, and SCCM.

Assessing the Brain Death/Death by Neurologic Criteria Determination Process in Korea: Insights from 10-Year Noncompleted Donation Data.

This study aimed to analyze the current status of brain death/death by neurologic criteria (BD/DNC) determination in Korea over a decade, identifying key areas for improvement in the process. We conducted a retrospective analysis of data from the Korea Organ Donation Agency spanning 2011 to 2021, focusing on donors whose donations were not completed. The study reviewed demographics, medical settings, diagnoses, and outcomes, with particular emphasis on cases classified as nonbrain death and those resulting in death by cardiac arrest during the BD/DNC assessment. Of the 5047 patients evaluated for potential brain death from 2011 to 2021, 361 were identified as noncompleted donors. The primary reasons for noncompletion included nonbrain death (n = 68, 18.8%), cardiac arrests during the BD/DNC assessment process (n = 80, 22.2%), organ ineligibility (n = 151, 41.8%), and logistical and legal challenges (n = 62, 17.2%). Notably, 25 (36.8%) of them failed to meet the minimum clinical criteria, and 7 of them were potential cases of disagreement between the two clinical examinations. Additionally, most cardiac arrests (n = 44, 55.0%) occurred between the first and second examinations, indicating management challenges in critically ill patients during the assessment period. Our study highlights significant challenges in the BD/DNC determination process, including the need for improved consistency in neurologic examinations and the management of critically ill patients. The study underscores the importance of refining protocols and training to enhance the accuracy and reliability of brain death assessments, while also ensuring streamlined and effective organ donation practices.

Paraneoplastic Neurologic Disorders.

This article reviews the clinical presentations, neural antibody associations, and oncologic accompaniments of paraneoplastic neurologic syndromes and neurologic autoimmunity in the context of immune checkpoint inhibitor (ICI) cancer immunotherapy. Neural antibody discovery has improved the diagnosis of paraneoplastic neurologic syndromes. Neural antibodies also delineate the underlying disease pathophysiology and thus inform outcomes and treatments. Neural antibodies specific for extracellular proteins have pathogenic potential, whereas antibodies specific for intracellular targets are biomarkers of a cytotoxic T-cell immune response. A recent update in paraneoplastic neurologic syndrome criteria suggests high- and intermediate-risk phenotypes as well as neural antibodies to improve diagnostic accuracy in patients with paraneoplastic neurologic syndromes; a score was created based on this categorization. The introduction of ICI cancer immunotherapy has led to an increase in cancer-related neurologic autoimmunity with distinct clinical phenotypes. Paraneoplastic neurologic syndromes reflect an ongoing immunologic response to cancer mediated by effector T cells or antibodies. Paraneoplastic neurologic syndromes can present with manifestations at any level of the neuraxis, and neural antibodies aid diagnosis, focus cancer screening, and inform prognosis and therapy. In patients with high clinical suspicion of a paraneoplastic neurologic syndrome, cancer screening and treatment should be undertaken, regardless of the presence of a neural antibody. ICI therapy has led to immune-mediated neurologic complications. Recognition and treatment lead to improved outcomes.

Brain death: A review of the latest guidelines.

The incidence of brain death/death by neurologic criteria (BD/DNC) among all hospital deaths in the US is approximately 2.06% or 15,000-20,000 cases annually. This article reviews the latest guidelines for adult and pediatric BD/DNC. Although there have not been many changes to the guidelines over the years, BD/DNC guideline updates maintain consistency in determining BD/DNC.

Computed Tomography Angiography as Ancillary Testing for Death Determination by Neurologic Criteria: A Technical Review.

The determination of death by neurological criteria (DNC) stands as a pivotal aspect of medical practice, involving a nuanced clinical diagnosis. Typically, it comes into play following a devastating brain injury, signalling the irreversible cessation of brain function, marked by the absence of consciousness, brainstem reflexes, and the ability to breathe autonomously. Accurate DNC diagnosis is paramount for adhering to the 'Dead donor rule', which permits organ donation solely from deceased individuals. However, complexities inherent in conducting a comprehensive DNC examination may impede reaching a definitive diagnosis. To address this challenge, ancillary testing such as computed tomography angiography (CTA) has emerged as a valuable tool. The aim of our study is to review the technique and interpretation of CTA for DNC diagnoses. CTA, a readily available imaging technique, enables visualization of the cerebral vasculature, offering insights into blood flow to the brain. While various criteria and scoring systems have been proposed, a universally accepted standard for demonstrating full brain circulatory arrest remains elusive. Nonetheless, leveraging CTA as an ancillary test in DNC assessments holds promise, facilitating organ donation and curbing healthcare costs. It is crucial to emphasize that DNC diagnosis should be exclusively entrusted to trained physicians with specialized DNC evaluation training, underscoring the importance of expertise in this intricate medical domain.

Prospective Evaluation of a Modified Apnea Test in Brain Death Candidates that Does Not Require Disconnection from the Ventilator.

The apnea test (AT) is an important component in the determination of brain death/death by neurologic criteria (BD/DNC) and often entails disconnecting the patient from the ventilator followed by tracheal oxygen insufflation to ensure adequate oxygenation. To rate the test as positive, most international guidelines state that a lack of spontaneous breathing must be demonstrated when the arterial partial pressure of carbon dioxide (PaCO2)≥ 60mm Hg. However, the loss of positive end-expiratory pressure that is associated with disconnection from the ventilator may cause rapid desaturation. This, in turn, can lead to cardiopulmonary instability (especially in patients with pulmonary impairment and diseases such as acute respiratory distress syndrome), putting patients at increased risk. Therefore, this prospective study aimed to investigate whether a modified version of the AT (mAT), in which the patient remains connected to the ventilator, is a safer yet still valid alternative. The mAT was performed in all 140 BD/DNC candidates registered between January 2019 and December 2022: after 10min of preoxygenation, (1) positive end-expiratory pressure was increased by 2mbar (1.5mm Hg), (2) ventilation mode was switched to continuous positive airway pressure, and (3) apnea back-up mode was turned off (flow trigger 10 L/min). The mAT was considered positive when spontaneous breathing did not occur upon PaCO2 increase to ≥ 60mm Hg (baseline 35-45mm Hg). Clinical complications during/after mAT were documented. The mAT was possible in 139/140 patients and had a median duration of 15min (interquartile range 13-19min). Severe complications were not evident. In 51 patients, the post-mAT arterial partial pressure of oxygen (PaO2)was lower than the pre-mAT PaO2, whereas it was the same or higher in 88 cases. In patients with pulmonary impairment, apneic oxygenation during the mAT improved PaO2. In 123 cases, there was a transient drop in blood pressure at the end of or after the mAT, whereas in 12 cases, the mean arterial pressure dropped below 60mm Hg. The mAT is a safe and protective means of identifying patients who no longer have an intact central respiratory drive, which is a critical factor in the diagnosis of BD/DNC. Clinical trial registration DRKS, DRKS00017803, retrospectively registered 23.11.2020, https://drks.de/search/de/trial/DRKS00017803.

The Role of S100b Protein Biomarker in Brain Death: A Literature Review.

Brain death (BD) represents the irreversible loss of all brain functions, including the brainstem, and is equivalent to clinical death established by neurological criteria. However, clinical diagnosis, mainly based on the absence of primary reflexes post-acute brain injury, remains a challenge in hospital settings. The S100 calcium-binding protein beta (S100b)is used to monitorbrain injuries, as recommended by neurotrauma care guidelines in some countries. Its levels are associated with severity and mortality, particularly after traumatic brain injury (TBI) and cerebral hemorrhage. The evaluation of S100b levels in investigating brain death is promising; however, aspects such as cutoff values remain to be elucidated. This paper reviews the literature on the use of S100b as a biomarker in diagnosing brain death. It is noteworthy that there is still no defined cutoff for S100b levels in confirming brain death. Additionally, when considering the use of S100b in emergency situations, a point-of-care methodology should be established to support clinical decision-making quickly and easily in the early identification of patients who are more likely to progress to brain death. In this context, S100b levels may assist in establishing the diagnosis of brain death, complementing existing clinical evidence. This, in turn, can optimize and qualify the organ donation process, reducing costs with ineffective therapies and minimizing the suffering of the families involved.

Role of Clinical and Multimodality Neuroimaging in the Evaluation of Brain Death/Death by Neurologic Criteria and Recent Highlights from 2023 Updated Guidelines.

Purpose of Review: This review aims to provide a comprehensive overview of the diagnosis of brain death/death by neurologic criteria (BD/DNC) by emphasizing the clinical criteria established by the American Academy of Neurology (AAN) in light of their updated guidelines released in 2023. In this review, we will focus on the current implementation of ancillary tests including the catheter cerebral angiogram, nuclear scintigraphy, and transcranial Doppler, which provide support in diagnoses when clinical examination and apnea tests are inconclusive. Finally, we will also provide examples to discuss the implementation of certain imaging studies in the context of diagnosing BD/DNC. Recent Findings: Recent developments in the field of neurology have emphasized the importance of clinical criteria for diagnosing BD/DNC, with the AAN providing clear updated guidelines that include coma, apnea, and the absence of brainstem reflexes. Current ancillary tests, including the catheter cerebral angiogram, nuclear scintigraphy, and transcranial Doppler play a crucial role in confirming BD/DNC when the clinical assessment is limited. The role of commonly used imaging studies including computed tomography and magnetic resonance angiographies of the brain as well as CT/MR perfusion studies will also be discussed in the context of these new guidelines. Summary: BD/DNC represents the permanent cessation of brain functions, including the brainstem. This review article provides the historical context, clinical criteria, and pathophysiology that goes into making this diagnosis. Additionally, it explores the various ancillary tests and selected imaging studies that are currently used to diagnose BD/DNC under the newly updated AAN guidelines. Understanding the evolution of how to effectively use these diagnostic tools is crucial for healthcare professionals who encounter these BD/DNC cases in their practice.

Calcineurin Inhibitor in NEuRoloGically deceased donors to decrease kidney delayed graft function study: study protocol of the CINERGY Pilot randomised controlled trial

IntroductionMost 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...

Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial

Expanded criteria donors help to increase graft availability, but provide organs with an increased risk of delayed graft function. We aimed to investigate whether donor hypothermia decreases the risk of delayed graft function compared with normothermia. We did this multicentre, randomised, controlled, parallel-arm trial at 53 intensive care units and transplant centres in France. We included expanded criteria donors in whom death was diagnosed based on neurological criteria, in compliance with French law, and the recipients of their kidney grafts. Eligible expanded criteria donors were older than 60 years or were aged 50-59 years and had at least two other risk factors (history of hypertension, creatinine >132 μmol/L, or cerebrovascular cause of death). Donors were randomly assigned to hypothermia (34-35°C) or normothermia (36·5-37·5°C). Machine perfusion was used routinely. Randomisation was done using a computer-generated, interactive, web-response system, in permuted blocks (block size six), stratified by centre. Outcome assessors were masked; investigator masking was not feasible. The primary outcome was the proportion of kidney recipients with delayed graft function, defined as renal replacement therapy within 7 days after transplantation, assessed in the modified intention-to-treat (mITT) population, which included all recipients who received at least one kidney from an expanded criteria donor, with the exception of those under guardianship. Secondary outcomes in expanded criteria donors were the number of organs recovered and transplanted, kidney function, body temperature, total volume of fluids administered, blood pressure and need for vasopressors and inotropes, and adverse events (cardiovascular events, metabolic disturbances, and coagulation disorders). Secondary outcomes in kidney recipients were duration of hospital stay, kidney graft function and vital status at day 7, day 28, 3 months, and 1 year after transplantation, and adverse events (infections, cardiovascular events, and surgical complications). Secondary outcomes were assessed in the mITT population. The trial was registered at ClinicalTrials.gov, NCT03098706. Between Nov 9, 2017, and March 3, 2021, 365 donors were randomly assigned, of whom 298 (151 [51%] male, 147 [49%] female) provided kidneys to 526 recipients (323 [61%] male, 203 [39%] female). 251 recipients in the hypothermia group and 275 recipients in the normothermia group were included in the analysis. Graft function was delayed in 40 (16%) of 251 recipients in the hypothermia group and 58 (21%) of 275 recipients in the normothermia group (odds ratio 0·71 [95% CI 0·44-1·13]; p=0·14; absolute difference -5·2% [95% CI 11·8-1·5]). Compared with donors in the normothermia group, donors in the hypothermia group had higher highest mean arterial pressure (115 mm Hg [SD 22] vs 108 mm Hg [20]; p=0·001). 1 year after transplantation, recipients in the hypothermia group had a lower mean creatinine concentration (152·4 μmol/L [SD 59·1] vs 169·7 μmol/L [51·4]; p=0·0351) and a higher mean creatinine clearance (42·3 mL/min/1·73 m2 [15·8] vs 40·5 mL/min/1·73 m2 [17·9]; p=0·0414) than those in the normothermia group. No significant differences between groups were identified for any other secondary outcomes. Hypothermia in expanded criteria donors whose organs were routinely stored using machine perfusion did not decrease the frequency of delayed kidney graft function. However, hypothermia was associated with a lower serum creatinine concentration and a higher creatinine clearance 1 year after transplantation. French Ministry of Health and French Intensive Care Society.