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The HYBERNATUS (Hypothermia for brain Enhancement restoration by using Neuroprotective and Anticonvulsivant motion after Convulsive status Epilepticus) trial was a multicenter, open-label, parallel-group, randomized, managed trial that changed into performed in eleven French ICUs from March 2011 via January 2015. The trial protocol has been published previously21 and is attainable with the total text of this text at NEJM.org. Approval changed into received from an independent ethics committee (Comité de protection des Personnes d’Ile de France IV, Saint Louis) and from the French fitness authorities (Agence Française de Sécurité Sanitaire des Produits de Santé). A steering committee offered information all over the trial. An impartial information and protection monitoring board (see the Supplementary Appendix, obtainable at NEJM.org) reviewed the facts and carried out a scheduled, blinded meantime evaluation. The trial become investigator-initiated, and there become no industry assist or involvement. The authors vouch for the habits of the trial, adherence to the protocol, and the accuracy and completeness of the facts and analyses.
The trial complied with the provisions of the announcement of Helsinki, respectable clinical apply instructions, and French regulatory requirements. The sufferers have been unable to supply informed consent at inclusion. based on French legislations, the ethics committee waived the requirement for acquiring recommended consent from sufferers because of the emergency surroundings of the analysis. before inclusion, investigators sought consent for participation from surrogates. If the surrogates selected no longer to supply consent, the sufferers were now not blanketed. Written consent became then requested from all blanketed sufferers as quickly as they regained competence.Inclusion and Exclusion standards
All sufferers older than 18 years of age who have been admitted with any seizure exercise to the participating ICUs had been screened for eligibility via the ICU physicians, and a log of all screened patients changed into retained. Eligible sufferers had convulsive fame epilepticus, defined as 5 minutes or extra of continual clinical seizure recreation or more than two seizures with no return to baseline in the interval; had been admitted less than 8 hours after the onset of seizures; and were receiving mechanical ventilation. Exclusion standards have been full healing from seizure (described as a return to the baseline state of cognizance), a necessity for emergency surgery that might avoid therapeutic hypothermia, postanoxic repute epilepticus, coming near near loss of life, and do-now not-resuscitate orders; an exclusion for bacterial meningitis become brought in January 2013, after the effects of a analyze indicated that reasonable hypothermia may be hazardous in people with extreme bacterial meningitis.22Randomization
Consecutive eligible patients had been assigned in a 1:1 ratio to some of the two medicine organizations with using a pc-generated scheme with permuted blocks and stratification in keeping with middle, age (≤sixty five or >sixty five years), and seizure length (≤60 or >60 minutes). Concealment of trial-community assignments become ensured by the use of a relaxed, noninteractive net-based mostly system that changed into accessible from each and every trial center and that became managed by means of the biostatistical unit of the Saint Louis university clinic (Paris), which had no different function in affected person recruitment.Trial Intervention
in the hypothermia community, the purpose changed into to decrease the core body temperature to 32 to 34°C as rapidly as viable after randomization and to retain this goal temperature for twenty-four hours. Hypothermia turned into prompted with ice-cold intravenous fluids at 4°C and became maintained with ice packs at the groin and neck and a chilly-air tunnel around the affected person’s physique (for particulars, see the strategies area in the Supplementary Appendix). Sedation turned into carried out with propofol and neuromuscular blockade. within the handle community, if the surgeon determined that sedation become necessary, a propofol regimen that changed into the same as that within the therapeutic hypothermia neighborhood changed into used. In both corporations, continuous EEG monitoring become begun inside 2 hours after randomization and become maintained for 48 hours after randomization or unless body temperature was normalized within the hypothermia group.23 A 30-minute general EEG segment extracted from the continual EEG recording turned into interpreted at a relevant website through a neurophysiologist within 2 hours after the initiation of continuous EEG. In each businesses, if the effects showed ongoing seizures, repeated propofol boluses had been administered, followed by means of a protection intravenous infusion to achieve and maintain a burst-suppression EEG pattern for 24 hours. Core body temperature was monitored perpetually with the use of an esophageal probe and turned into recorded every four hours throughout the primary 48 hours after randomization. sufferers had been screened for propofol-connected infusion syndrome every 8 hours all over the primary forty eight hours after randomization. further particulars of remedies are provided within the Supplementary Appendix.effects and Assessments
The fundamental influence was the absence of practical impairment ninety days after reputation epilepticus, as defined with the aid of a ranking of 5 on the Glasgow result Scale (GOS), indicating survival with respectable characteristic that allowed a return to former occupational or academic activities, with or without minor physical or intellectual deficits (the GOS degrees from 1 to five, with 1 representing death and 5 representing no or minimal neurologic deficit). The ranking changed into determined throughout a structured interview that changed into carried out at ninety±7 days via an impartial assessor.
Secondary outcomes had been the fees of death in the ICU, within the sanatorium, and by day 90; development to EEG-established status epilepticus, described as coma with or without refined convulsive movements but with generalized or lateralized ictal discharges on the EEG between 6 and 12 hours after randomization; refractory popularity epilepticus on day 1, described as continual or intermittent clinical seizures, EEG-validated seizures, or each regardless of two types of antiepileptic medicine within 24 hours after the onset of reputation epilepticus; super-refractory status epilepticus, defined as ongoing or recurrent status epilepticus between 24 and 48 hours after the initiation of anesthetic medication; total seizure duration; lengths of dwell in the ICU and in the sanatorium; and, in a subset of patients, impairments on day 90 (as determined through new seizures, recurrent status epilepticus after discharge, the variety of antiepileptic drugs being used, and the ranking on the Mini–intellectual State Examination [MMSE; range, 0 to 30, with higher scores representing better performance]).
Physicians who assessed results, trial administrators, and statisticians had been unaware of the trial-group assignments. At ninety±7 days, 60 of the 270 patients agreed to an further assessment with the aid of a neurologist who become ignorant of the trial-neighborhood assignments; the contrast included an interview and determination of the GOS and MMSE scores. earlier than this consult with, the sufferers underwent magnetic resonance imaging of the brain and conventional EEG at their local hospitals and introduced the scans and EEG outcomes to the consult with. The neurologist referred to from affected person interviews and clinic charts any episodes of recurrent convulsive reputation epilepticus due to the fact that randomization; the frequency of any recurrent seizures, as well as their class and linked signs; and the nature and dose of antiepileptic medication and other treatments.Statistical evaluation
All analyses have been performed in response to a prior to now posted statistical analysis plan.21 They calculated that 135 patients per neighborhood would need to be enrolled for the trial to have 90% vigour to observe an absolute change of 20 percent aspects within the percent of patients with a GOS rating of 5 on day ninety (forty% in the ordinary-care group4,8 vs. 60% in the hypothermia neighborhood), at an alpha degree of 0.05.
A single scheduled interim evaluation turned into carried out to verify efficacy after enrollment of fifty% of the planned cohort, with the use of a two-sided, symmetric O’Brien–Fleming design and a two-sided alpha level of 0.005. This analysis turned into reviewed with the aid of the unbiased records and defense monitoring board. It yielded a P price of 0.18, a effect that led to continuation of the trial and enrollment of the total sample.
continuous variables are summarized as medians and interquartile stages and categorical variables as counts and percentages. The fundamental effect changed into in comparison between groups with using a logistic mannequin stratified according to the randomization stratification variables with using a Wald look at various. different binary outcomes (mortality in the ICU, in-health center mortality, the percent of sufferers with refractory reputation epilepticus, total seizure length, and recurrence of reputation epilepticus after discharge) have been in a similar fashion analyzed. Survival within each and every community became estimated by way of the Kaplan–Meier formula with censoring on day 90, and survival prices have been in comparison with the use of the log-rank test. Median durations of health facility and ICU stays had been estimated in both companies with using a Kaplan–Meier estimator and validated with the use of a log-rank look at various, with discharge alive because the experience of activity and loss of life as the censoring adventure. total seizure length, variety of antiepileptic drugs, and MMSE ranking have been compared with using the Wilcoxon rank-sum test. Seizure and status epilepticus recurrences had been compared with using the Fisher’s accurate verify. They carried out 13 exams for secondary results; hence, fewer than 1 examine could be expected to have a major outcome (P<0.05) on the groundwork of chance on my own.
We conducted exploratory analyses of the primary outcomes in subgroups, building logistic-regression models to compare odds ratios, with their ninety five% self assurance intervals, for success of a GOS ranking of 5. They first looked for quantitative interplay between the intervention and randomization stratification variables the usage of the Gail and Simon heterogeneity verify.24 In case of opposite course in odds ratios, qualitative interplay became further tested with using the Silvapulle test.25
All analyses were performed in line with the intention-to-deal with precept; missing values were dealt with with the use of the ultimate-statement-carried-ahead method. Sensitivity analyses of the simple outcome were performed, including the use of dissimilar imputation for lacking information by way of potential of chained equations (20 records units imputed) and a per-protocol method that included all patients who obtained the intervention and were enrolled in the trial handiest as soon as.
All reported P values are two-sided, and P values of lower than 0.05 had been considered to indicate statistical magnitude. Analyses had been carried out with R software, version three.3.1 (www.R-mission.org/).
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