Dataset Information

A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.

ABSTRACT:

Context

Hypothermia improves neurological outcome for comatose survivors of out-of-hospital cardiac arrest. Use of computer controlled high surface area devices for cooling may lead to faster cooling rates and potentially improve patient outcome.

Objective

To compare the effectiveness of surface cooling with the standard blankets and ice packs to the Arctic Sun, a mechanical device used for temperature management.

Design, setting, and patients

Multi-center randomized trial of hemodynamically stable comatose survivors of out-of-hospital cardiac arrest.

Intervention

Standard post-resuscitative care inducing hypothermia using cooling blankets and ice (n=30) or the Arctic Sun (n=34).

Main outcome measures

The primary end point was the proportion of subjects who reached a target temperature within 4h of beginning cooling. The secondary end points were time interval to achieve target temperature (34 degrees C) and survival to 3 months.

Results

The proportion of subjects cooled below the 34 degrees C target at 4h was 71% for the Arctic Sun group and 50% for the standard cooling group (p=0.12). The median time to target was 54 min faster for cooled patients in the Arctic Sun group than the standard cooling group (p<0.01). Survival rates with good neurological outcome were similar; 46% of Arctic Sun patients and 38% of standard patients had a cerebral performance category of 1 or 2 at 30 days (p=0.6).

Conclusions

While the proportion of subjects reaching target temperature within 4h was not significantly different, the Arctic Sun cooled patients to a temperature of 34 degrees C more rapidly than standard cooling blankets.

SUBMITTER: Heard KJ

PROVIDER: S-EPMC2815241 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

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Publications

A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.

Heard Kennon J KJ Peberdy Mary Ann MA Sayre Michael R MR Sanders Arthur A Geocadin Romergryko G RG Dixon Simon R SR Larabee Todd M TM Hiller Katherine K Fiorello Albert A Paradis Norman A NA O'Neil Brian J BJ

Resuscitation 20091024 1

<h4>Context</h4>Hypothermia improves neurological outcome for comatose survivors of out-of-hospital cardiac arrest. Use of computer controlled high surface area devices for cooling may lead to faster cooling rates and potentially improve patient outcome.<h4>Objective</h4>To compare the effectiveness of surface cooling with the standard blankets and ice packs to the Arctic Sun, a mechanical device used for temperature management.<h4>Design, setting, and patients</h4>Multi-center randomized trial ...[more]

PMID: 19854555

Similar Datasets

Project description:To assess the feasibility, effectiveness, side effects, and adverse events associated with a standardized surface cooling protocol. Induced therapeutic hypothermia after pediatric cardiac arrest is an important intervention.Prospective intervention trial.Urban, tertiary care children's hospital.Twelve pediatric cardiac arrest survivors.Standardized surface cooling protocol.Patients (age: median, 1.5 yrs; interquartile range, 0.5-6.25; cardiopulmonary resuscitation duration: median, 18 mins; interquartile range, 10-45) were cooled by a standard surface cooling protocol for rapid induction and maintenance of goal rectal temperature (T) 32°C-34°C for 24 hrs, with prospectively defined rescue protocols. Side effects and clinical interventions were recorded. Median time to rectal T ?34°C was 1.5 (1, 1.5) hrs from cooling initiation and 6 (5, 6.5) hrs from arrest. T was documented every 30 mins. Maintenance target T 32°C-34°C was attained in 78% (414 of 531) of measurements, overshoot hypothermia <32°C in 15% (81 of 531), and overshoot hyperthermia >34°C in 7% (36 of 531). Mean bias between rectal vs. esophageal T was -0.42°C (95% confidence interval, -0.49 to -0.35), and between rectal and bladder T was 0.16°C (95% confidence interval, 0.11-0.22). Side effects observed included: hypokalemia <3.0 mEq/L in 67% of patients and bradycardia <2% for age in 58%. There were no episodes of bleeding or ventricular tachyarrhythmia that required treatment. Six (50%) of 12 patients survived to discharge.A standard surface cooling protocol achieved rapid induction of hypothermia after pediatric cardiac arrest. During maintenance of hypothermia, 78% of measures were within target T 32°C-34°C. Commonly employed temperature sites (esophageal, rectal, and bladder) were similar. Overshoot hypothermia and associated side effects were common, but there were no serious adverse events attributable to induced therapeutic hypothermia in this case series. Surface cooling protocols to induce and maintain therapeutic hypothermia after pediatric cardiac arrest are potentially feasible.

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.

Project description:Meta-analyses of nonrandomized studies have provided conflicting data on therapeutic hypothermia, or targeted temperature management (TTM), at 33°C in patients successfully resuscitated after nonshockable cardiac arrest. Nevertheless, the latest recommendations issued by the International Liaison Committee on Resuscitation and by the European Resuscitation Council recommend therapeutic hypothermia. New data are available on the adverse effects of therapeutic hypothermia, notably infectious complications. The risk/benefit ratio of therapeutic hypothermia after nonshockable cardiac arrest is unclear.HYPERION is a multicenter (22 French ICUs) trial with blinded outcome assessment in which 584 patients with successfully resuscitated nonshockable cardiac arrest are allocated at random to either TTM between 32.5 and 33.5°C (therapeutic hypothermia) or TTM between 36.5 and 37.5°C (therapeutic normothermia) for 24 hours. Both groups are managed with therapeutic normothermia for the next 24 hours. TTM is achieved using locally available equipment. The primary outcome is day-90 neurological status assessed by the Cerebral Performance Categories (CPC) Scale with dichotomization of the results (1?+?2 versus 3?+?4?+?5). The primary outcome is assessed by a blinded psychologist during a semi-structured telephone interview of the patient or next of kin. Secondary outcomes are day-90 mortality, hospital mortality, severe adverse events, infections, and neurocognitive performance. The planned sample size of 584 patients will enable us to detect a 9% absolute difference in day-90 neurological status with 80% power, assuming a 14% event rate in the control group and a two-sided Type 1 error rate of 4.9%. Two interim analyses will be performed, after inclusion of 200 and 400 patients, respectively.The HYPERION trial is a multicenter, randomized, controlled, assessor-blinded, superiority trial that may provide an answer to an issue of everyday relevance, namely, whether TTM is beneficial in comatose patients resuscitated after nonshockable cardiac arrest. Furthermore, it will provide new data on the tolerance and adverse events (especially infectious complications) of TTM at 32.5-33.5°C.ClinicalTrials.gov: NCT01994772 .

Project description:BACKGROUND:Targeted temperature management is recommended for comatose adults and children after out-of-hospital cardiac arrest; however, data on temperature management after in-hospital cardiac arrest are limited. METHODS:In a trial conducted at 37 children's hospitals, we compared two temperature interventions in children who had had in-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose children older than 48 hours and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function), was evaluated among patients who had had a VABS-II score of at least 70 before the cardiac arrest. RESULTS:The trial was terminated because of futility after 329 patients had undergone randomization. Among the 257 patients who had a VABS-II score of at least 70 before cardiac arrest and who could be evaluated, the rate of the primary efficacy outcome did not differ significantly between the hypothermia group and the normothermia group (36% [48 of 133 patients] and 39% [48 of 124 patients], respectively; relative risk, 0.92; 95% confidence interval [CI], 0.67 to 1.27; P=0.63). Among 317 patients who could be evaluated for change in neurobehavioral function, the change in VABS-II score from baseline to 12 months did not differ significantly between the groups (P=0.70). Among 327 patients who could be evaluated for 1-year survival, the rate of 1-year survival did not differ significantly between the hypothermia group and the normothermia group (49% [81 of 166 patients] and 46% [74 of 161 patients], respectively; relative risk, 1.07; 95% CI, 0.85 to 1.34; P=0.56). The incidences of blood-product use, infection, and serious adverse events, as well as 28-day mortality, did not differ significantly between groups. CONCLUSIONS:Among comatose children who survived in-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a favorable functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute; THAPCA-IH ClinicalTrials.gov number, NCT00880087 .).

Dataset Information

A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.

Context

Objective

Design, setting, and patients

Intervention

Main outcome measures

Results

Conclusions

Publications

A randomized controlled trial comparing the Arctic Sun to standard cooling for induction of hypothermia after cardiac arrest.

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