Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest

Study Overview
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Brief Summary
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Mild therapeutic hypothermia in the temperature range of 32º - 34ºC. improves survival in patients recovered from a ventricular fibrillation cardiac arrest. The same therapy is suggested with less evidence for asystole as first rhythm after cardiac arrest. The purpose of this study is to determine whether different temperature targets (32º vs 34º) may have different efficacy in the treatment of post-cardiac arrest patients. If successful, this pilot study will eventually form the basis for a larger, multicentric randomized clinical trial.

Detailed Description
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Patients admitted consecutively were potentially eligible for the study if they had a witnessed out-off hospital cardiac arrest (OHCA) apparently related to heart disease and an interval of <60 minutes from collapse to return of spontaneous circulation (ROSC). Additional inclusion criteria were: Age >18 years. Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole. Exclusion criteria were: Known pregnancy Glasgow Coma Scale score after ROSC >8. Cardiogenic shock (a systolic blood pressure of <80 mm Hg despite inotrope infusion >30 minutes). Other nonshockable rhythms (pulseless electric activity). Terminal illness present before the OHCA. Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).

Official Title
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Pilot Randomized Clinical Trial Comparing the Efficacy of Two Different Hypothermia Temperatures for Treatment of Comatose Patients Recovered From an Out-of-hospital Cardiac Arrest

Conditions
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Non-environmental Hypothermia, Cardiac Arrest

Intervention / Treatment
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* Procedure: Endovascular Cooling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Resuscitated patients from a cardiac arrest with first rhythm of ventricular fibrillation or asystole Witnessed cardiac arrest Estimated delay between cardiac arrest and advanced resuscitation < 20 min. Resuscitation time from first contact to recovery of spontaneous circulation < 60 min. Hemodynamic stability (Mean blood pressure [BP] >60 mmHg), with or without inotropic drugs, before randomization Glasgow coma score <9 without sedation before randomization Exclusion Criteria: Pregnant women or suspected pregnancy or fertile women without a negative pregnancy test Suspected non-cardiac arrest caused coma Electrical instability (uncontrollable life-threatening arrhythmias) Hemodynamic instability (Mean BP ≤60 mmHg), refractory to volume infusion or inotropic drugs Refractory hypoxemia (saturation <85% with FiO2=100%) Previous known terminal illness Active bleeding or known coagulopathy Opposition from patient's family to enter the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 32º Celsius<br>Endovascular Cooling was set at a target temperature of 32°C | Procedure: Endovascular Cooling<br>* Infusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.<br>|
| Active Comparator: 34º Celsius<br>Endovascular Cooling was set at a target temperature of 32°C | Procedure: Endovascular Cooling<br>* Infusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival free from severe dependence (Barthel index <60) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 6 months |  | 6 months | 
| Barthel Index at 6 months |  | 6 months | 
| Life threatening arrhythmias in different hypothermia temperatures | New life-threatening arrhythmias during hypothermia: ventricular fibrillation, sustained (>30 sec.) monomorphic or polymorphic ventricular tachycardia, extreme bradycardia (heart rate <35 bpm. and/or pauses >3 sec.) | 48 hours (during hypothermia) | 
| Impact on ventricular function of different hypothermia temperatures | Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function | 48 hours During hypothermia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, induced, Cardiac arrest, Disability evaluation, Cardiac arrhythmia, Ventricular function, Internal cooling, Out-of-hospital cardiac arrest, Post-cardiac arrest syndrome