One-Year Review in Cardiac Arrest: The 2022 Randomized Controlled Trials.
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SUBMITTER: Penna A
PROVIDER: S-EPMC10054058 | biostudies-literature | 2023 Mar
REPOSITORIES: biostudies-literature
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One-Year Review in Cardiac Arrest: The 2022 Randomized Controlled Trials.
Penna Alessio A Magliocca Aurora A Merigo Giulia G Stirparo Giuseppe G Silvestri Ivan I Fumagalli Francesca F Ristagno Giuseppe G
Journal of clinical medicine 20230314 6
Cardiac arrest, one of the leading causes of death, accounts for numerous clinical studies published each year. This review summarizes the findings of all the randomized controlled clinical trials (RCT) on cardiac arrest published in the year 2022. The RCTs are presented according to the following categories: out-of- and in-hospital cardiac arrest (OHCA, IHCA) and post-cardiac arrest care. Interestingly, more than 80% of the RCTs encompassed advanced life support and post-cardiac arrest care, wh ...[more]
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Project description:BackgroundSeparate trials to evaluate therapeutic hypothermia after paediatric cardiac arrest for out-of-hospital and in-hospital settings reported no statistically significant differences in survival with favourable neurobehavioral outcome or safety compared to therapeutic normothermia. However, larger sample sizes might detect smaller clinical effects. Our aim was to pool data from identically conducted trials to approximately double the sample size of the individual trials yielding greater statistical power to compare outcomes.MethodsCombine individual patient data from two clinical trials set in forty-one paediatric intensive care units in USA, Canada and UK. Children aged at least 48 h up to 18 years old, who remained comatose after resuscitation, were randomized within 6 h of return of circulation to hypothermia or normothermia (target 33.0 °C or 36.8 °C). The primary outcome, survival 12 months post-arrest with Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score at least 70 (scored from 20 to 160, higher scores reflecting better function, population mean = 100, SD = 15), was evaluated among patients with pre-arrest scores ≥70.Results624 patients were randomized. Among 517 with pre-arrest VABS-II scores ≥70, the primary outcome did not significantly differ between hypothermia and normothermia groups (28% [75/271] and 26% [63/246], respectively; relative risk, 1.08; 95% confidence interval [CI], 0.81 to 1.42; p = 0.61). Among 602 evaluable patients, the change in VABS-II score from baseline to 12 months did not differ significantly between groups (p = 0.20), nor did, proportion of cases with declines no more than 15 points or improvement from baseline [22% (hypothermia) and 21% (normothermia)]. One-year survival did not differ significantly between hypothermia and normothermia groups (44% [138/317] and 38% [113/ 297], respectively; relative risk, 1.15; 95% CI, 0.95 to 1.38; p = 0.15). Incidences of blood-product use, infection, and serious cardiac arrhythmia adverse events, and 28-day mortality, did not differ between groups.ConclusionsAnalysis of combined data from two paediatric cardiac arrest targeted temperature management trials including both in-hospital and out-of-hospital cases revealed that hypothermia, as compared with normothermia, did not confer a significant benefit in survival with favourable functional outcome at one year.
| S-EPMC6361524 | biostudies-literature
Project description:ObjectiveThe study aim was to characterize the time-course of recovery in impairments, activity limitations, participation restrictions, disability, and quality of life during the first year after cardiac arrest. Secondarily, the study described the associations between the instruments used to measure each of these domains.MethodsMeasures of global disability (Cerebral Performance Category, CPC, Modified Rankin Scale, mRS), quality of life, activity limitations, participation restrictions, and affective and cognitive impairments were administered to 29 participants 1, 6, and 12 months after cardiac arrest.ResultsGlobal measures of disability indicated recovery between one month and one year after cardiac arrest (mean CPC: 2.1 versus 1.69, P < 0.05; mean mRS: 2.55 versus 1.83, P < 0.05). While global measures of disability were moderately associated with participation, they were poorly associated with other measures. The cohort endorsed depressive symptomatology throughout the year but did not have detectable cognitive impairment.ConclusionsRecovery from cardiac arrest is multifaceted and recovery continues for months depending upon the measures being used. Measures of global disability, reintegration into the community, and quality of life yield different information. Future clinical trials should include a combination of measures to yield the most complete representation of recovery after cardiac arrest.
| S-EPMC4573239 | biostudies-literature
Project description:IntroductionThe appropriate oxygen target post-resuscitation in out-of-hospital cardiac arrest (OHCA) patients is uncertain. We sought to compare lower versus higher oxygen targets in patients following OHCA.MethodsWe searched MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov until January 2023 to include all randomized controlled trials (RCTs) that evaluated conservative vs. liberal oxygen therapy in OHCA patients. Our primary outcome was all-cause mortality at 90 days while our secondary outcomes were the level of neuron-specific enolase (NSE) at 48 h, ICU length of stay (LOS), and favorable neurological outcome (the proportion of patients with Cerebral Performance Category scores of 1-2 at end of follow-up). We used RevMan 5.4 to pool risk ratios (RRs) and mean differences (MDs).ResultsNine trials with 1971 patients were included in our review. There was no significant difference between the conservative and liberal oxygen target groups regarding the rate of all-cause mortality (RR 0.95, 95% CI: 0.80 to 1.13; I2 = 55%). There were no significant differences between the two groups when assessing favorable neurological outcome (RR 1.01, 95% CI: 0.92 to 1.10; I2 = 4%), NSE at 48 h (MD 0.04, 95% CI: -0.67 to 0.76; I2 = 0%), and ICU length of stay (MD -2.86 days, 95% CI: -8.00 to 2.29 days; I2 = 0%).ConclusionsConservative oxygen therapy did not decrease mortality, improve neurologic recovery, or decrease ICU LOS as compared to a liberal oxygen regimen. Future large-scale RCTs comparing homogenous oxygen targets are needed to confirm these findings.
| S-EPMC10359856 | biostudies-literature
Project description:BackgroundCardiac arrest is a major public health concern worldwide. The extent and types of randomized controlled trials (RCT)-our most reliable source of clinical evidence-conducted in these high-risk patients over recent years are largely unknown.Methods and resultsWe performed a systematic review, identifying all RCTs published in PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library from 1995 to 2014 that focused on the acute treatment of nontraumatic cardiac arrest in adults. We then extracted data on the setting of study populations, types and timing of interventions studied, risk of bias, outcomes reported, and how these factors have changed over time. Over this 20-year period, 92 RCTs were published containing 64 309 patients (median, 225.5 per trial). Of these, 81 RCTs (88.0%) involved out-of-hospital cardiac arrest, whereas 4 (4.3%) involved in-hospital cardiac arrest and 7 (7.6%) included both. Eighteen RCTs (19.6%) were performed in the United States, 68 (73.9%) were performed outside the United States, and 6 (6.5%) were performed in both settings. Thirty-eight RCTs (41.3%) evaluated drug therapy, 39 (42.4%) evaluated device therapy, and 15 (16.3%) evaluated protocol improvements. Seventy-four RCTs (80.4%) examined interventions during the cardiac arrest, 15 (16.3%) examined post cardiac arrest treatment, and 3 (3.3%) studied both. Overall, reporting of the risk of bias was limited. The most common outcome reported was return of spontaneous circulation: 86 (93.5%) with only 22 (23.9%) reporting survival beyond 6 months. Fifty-three RCTs (57.6%) reported global ordinal outcomes, whereas 15 (16.3%) reported quality-of-life. RCTs in the past 5 years were more likely to be focused on protocol improvements and postcardiac arrest care.ConclusionsImportant gaps in RCTs of cardiac arrest treatments exist, especially those examining in-hospital cardiac arrest, protocol improvement, postcardiac arrest care, and long-term or quality-of-life outcomes.
| S-EPMC5339040 | biostudies-literature
Project description:BackgroundThe current guidelines recommend targeted temperature management (TTM) as part of the post-resuscitation care for comatose patients following out-of-hospital cardiac arrest. These recommendations are based on the weak evidence of benefit seen in the early clinical trials. Recent large multicentered trials have failed to show a meaningful clinical benefit of hypothermia, unlike the earlier studies. Thus, to fully appraise the available data, we sought to perform this systematic review and meta-analysis of randomized controlled trials.MethodsWe searched four databases for randomized controlled trials comparing therapeutic hypothermia (32-34 °C) with normothermia (≥36 °C with control of fever) in adult patients resuscitated after out-of-hospital cardiac arrest. Independent reviewers did the title and abstract screening, full-text screening, and extraction. The primary outcome was mortality six months after cardiac arrest, and secondary outcomes were neurological outcomes and adverse effects.Relevance for patientsSix randomized controlled trials were included in this review. There was no significant difference between the hypothermia and normothermia groups in mortality till 6 months follow up after out-of-hospital cardiac arrest (OR 0.88, 95% CI 0.67-1.16; n = 3243; I2 = 51%), or favorable neurological outcome (OR 1.31, 95% CI 0.93-1.84; n = 3091; I2 = 68%). Rates of arrhythmias were notably higher in the hypothermia group than the normothermia group (OR 1.43, 95% CI 1.20-1.71; n = 3029; I2 = 4%). However, odds for development of pneumonia showed no significant differences across two groups (OR 1.13, 95% CI 0.98-1.31; n = 3056; I2 = 22%). Therefore, targeted hypothermia with a target temperature of 32-34 °C does not provide mortality benefit or better neurological outcome in patients resuscitated after the out-of-hospital cardiac arrest when compared with normothermia.
| S-EPMC8818536 | biostudies-literature
Project description:IntroductionThe benefit of medications used in out-of-hospital, shock-refractory cardiac arrest remains controversial. This study aims to compare the treatment outcomes of medications for out-of-hospital, shock-refractory ventricular fibrillation (VF) or pulseless ventricular tachycardia (pVT).MethodsThe inclusion criteria were randomized controlled trials of participants older than eight years old who had atraumatic, out-of-hospital, shock-refractory VF/pVT in which at least one studied group received a medication. We conducted a database search on October 28, 2019, that included PubMed, Scopus, Web of Science, CINAHL Complete, and Cochrane CENTRAL. Citations of relevant meta-analyses were also searched. We performed frequentist network meta-analysis (NMA) to combine the comparisons. The outcomes were analyzed by using odds ratios (OR) and compared to placebo. The primary outcome was survival to hospital discharge. The secondary outcomes included the return of spontaneous circulation (ROSC), survival to hospital admission, and the neurological outcome at discharge. We ranked all outcomes using surface under the cumulative ranking score.ResultsWe included 18 studies with 6,582 participants. The NMA of 20 comparisons included 12 medications and placebo. Only norepinephrine showed a significant increase of ROSC (OR = 8.91, 95% confidence interval [CI], 1.88-42.29). Amiodarone significantly improved survival to hospital admission (OR = 1.53, 95% CI, 1.01-2.32). The ROSC and survival-to-hospital admission data were significantly heterogeneous with the I2 of 55.1% and 59.1%, respectively. This NMA satisfied the assumption of transitivity.ConclusionNo medication was associated with improved survival to hospital discharge from out-of-hospital, shock-refractory cardiac arrest. For the secondary outcomes, norepinephrine was associated with improved ROSC and amiodarone was associated with an increased likelihood of survival to hospital admission in the NMA.
| S-EPMC8328185 | biostudies-literature
Project description:ObjectivesDespite the significant disease burden due to cardiac arrest, there is a relative paucity of randomized controlled trials (RCTs) to inform definitive management. We aimed to evaluate the current scope of cardiac arrest RCTs published between 2015 and 2022.MethodsWe conducted a search in October 2023 of MEDLINE, Embase, and Web of Science for cardiac arrest RCTs. We included trials published between 2015 and 2022 enrolling human subjects suffering from non-traumatic cardiac arrest. Descriptive statistics were reported and the Mann Kendall test was used to evaluate for temporal trends in the number of trials published annually.ResultsWe identified 1764 unique publications, 87 RCTs were included after title/abstract and full-text review. We found no significant increase in trials published annually (eight in 2015 and 16 in 2022, p = 1.0). Geographic analysis of study centers found 31 countries represented; Denmark (n = 13, 15%) and the United States (n = 9, 10%) conducted the majority of trials. Nearly all trials included adults (n = 84, 97%) and few included children (n = 9, 10%). The majority of trials focused on out-of-hospital cardiac arrest (n = 62, 71%). Thirty-eight (44%) trials used an intervention characterized as a process improvement; 28 (32%) interventions were characterized as a drug and 20 (23%) as a device. Interventions were implemented with similar frequency in the prehospital (33%) and intensive care unit (38%) setting, as well as similarly between the intra-arrest (53%) and post-arrest (46%) periods. Twenty (27%) trials selected a primary outcome of survival at ≥ 28 days.ConclusionsPublication of cardiac arrest RCTs remained constant between 2015 and 2022. We identified significant gaps including a lack of trials examining in-hospital cardiac arrest and pediatric patients.
| S-EPMC11486800 | biostudies-literature
Project description:ImportanceLittle is known about neuropsychological outcomes of children who survived pediatric cardiac arrest (CA).ObjectiveTo describe the neuropsychological outcomes of CA survivors enrolled in the Therapeutic Hypothermia After Pediatric Cardiac Arrest In-Hospital (THAPCA-IH) and Out-of-Hospital (THAPCA-OH) trials and compare the results with the primary outcome measure for these trials.Design, setting, and participantsSecondary analysis of 222 CA survivors aged 1 to 18 years who received chest compressions for 2 minutes or more, remained comatose and required mechanical ventilation after return of circulation, and were enrolled in targeted temperature-management trials from 41 pediatric intensive care units. Data were collected from September 3, 2009, to February 3, 2016, and analyzed from March 10, 2017, to April 20, 2018.Main outcomes and measuresThe Vineland Adaptive Behavior Scales, Second Edition (VABS-II), a standardized measure of neurobehavioral functioning based on caregiver report (age-corrected mean [SD] scores = 100 [15]), was used to evaluate pre-CA functioning within 24 hours after enrollment; VABS-II<70 indicated significant developmental delays; VABS-II and neuropsychological testing were completed 1 year after CA. Neuropsychological testing included the Mullen Scales of Early Learning (Mullen) for children younger than 6 years and the Wechsler Abbreviated Scale of Intelligence (WASI) and neuropsychological measures of attention, memory, processing speed, and executive functioning for older children.ResultsOf 160 participants who completed neuropsychological testing, 96 (60.0%) were male; the median (interquartile range [IQR]) age was 2.5 years (1.3-6.1 years). Ninety-six (60.0%) were white, 41 (25.6%) were black, and 23 (14.4%) were of other/unknown race; 343 (21.2%) were Hispanic or Latino; 119 (74.4%) were non-Hispanic or Latino; and 7 (4.4%) were of unknown ethnicity. One hundred fourteen participants (71.2%) were classified as having favorable outcomes (VABS-II ≥70). Impairments (>2 SD below the mean for age) across neuropsychological measures ranged from 7% to 61%. Correlations between global cognitive and VABS-II scores were strong for younger children (Mullen, r = 0.69-0.87) but moderate for older children (r = 0.21-0.54 for the WASI). Of 111 children with favorable outcomes on VABS-II, 25.2% had global cognitive impairment and 30 of 35 older children (85.7%) had selective neuropsychological deficits.Conclusions and relevanceIn this prospectively evaluated cohort of pediatric CA survivors who were initially comatose, although 71.2% were classified as having favorable outcomes, significant neuropsychological deficits were identified in pediatric CA survivors who were classified as having favorable outcomes. The findings provide clinicians with a greater understanding of the spectrum of neuropsychological outcomes of pediatric CA survivors and the complex relationship between standardized caregiver-reported functional outcome measures incorporated in clinical trials and performance-based neuropsychological assessments.
| S-EPMC6583192 | biostudies-literature
Project description:Guidelines recommend mild therapeutic hypothermia (MTH) for survivors of out-of-hospital cardiac arrest (OHCA). However, there is little literature demonstrating a survival benefit. We performed a meta-analysis of randomized controlled trials (RCTs) assessing the efficacy of MTH in patients successfully resuscitated from OHCA.Electronic databases were searched for RCT involving MTH in survivors of OHCA, and the results were put through a meta-analysis. The primary endpoint was all-cause mortality, and the secondary endpoint was favorable neurological function. Odds ratios (ORs) and 95% confidence intervals (CIs) were computed using the Mantel-Haenszel method. A fixed-effect model was used and, if heterogeneity (I2 ) was >40, effects were analyzed using a random model.Six RCT (n = 1400 patients) were included. Overall survival was 50.7%, and favorable neurological recovery was 45.5%. Pooled data demonstrated no significant all-cause mortality (OR, 0.81; 95% CI 0.55-1.21) or neurological recovery (OR, 0.77; 95% CI 0.47-1.24). No evidence of publication bias was observed.This meta-analysis demonstrated that MTH did not confer benefit on overall survival rate and neurological recovery in patients resuscitated from OHCA.
| S-EPMC4900372 | biostudies-other
Project description:BackgroundTargeted temperature management (TTM) is recommended in adult patients following cardiac arrest (CA) with any rhythm. However, as to non-shockable (NSR) CA, high-quality evidence of TTM supporting its practices remains uncertain. Thus, we aimed to conduct a systematic review and meta-analysis with randomized controlled trials (RCTs) to explore the efficacy and safety of TTM in this population.MethodsWe searched PubMed, Embase, and Cochrane library databases for potential trials from inception through Aug 25, 2021. RCTs evaluating TTM for CA adults due to NSR were included, regardless of the timing of cooling initiation. Outcome measurements were mortality and good neurological function. We used the Cochrane bias tools to evaluate the quality of the included studies. Heterogeneity, subgroup analyses, and sensitivity analysis were investigated to test the robustness of the primary outcomes.ResultsA total of 14 RCTs with 4,009 adults were eligible for the final analysis. All trials had a low to moderate risk of bias. Of the included trials, six compared NSR patients with or without TTM, while eight compared pre-hospital to in-hospital TTM. Pooled data showed that TTM was not associated with improved mortality (Risk ratio [RR] 1.00; 95% CI, 0.944-1.05; P = 0.89, I 2 = 0%) and good neurological outcome (RR 1.18; 95% CI 0.90-1.55; P = 0.22, I 2 = 8%). Similarly, use of pre-hospital TTM resulted in neither an improved mortality (RR 0.99, 95% CI 0.97-1.03; I 2 = 0%, P = 0.32) nor favorable neurological outcome (RR 1.13, 95% CI 0.93-1.38; I 2 = 0%, P = 0.22). These results were further confirmed in the sensitivity analyses and subgroup analyses.ConclusionsOur results showed that using the TTM strategy did not significantly affect the mortality and neurologic outcomes in CA survival presenting initial NSR.
| S-EPMC9203727 | biostudies-literature