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

Phase 4

Completed

• Conditions: Non-environmental Hypothermia; Cardiac Arrest
• Interventions: Procedure: Endovascular Cooling

• Registration Number: NCT01155622
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

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

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:

1. Age \>18 years.

2. Initial registered rhythm of a shockable rhythm (ventricular fibrillation or pulseless ventricular tachycardia) or asystole.

Exclusion criteria were:

1. Known pregnancy

2. Glasgow Coma Scale score after ROSC \>8.

3. Cardiogenic shock (a systolic blood pressure of \<80 mm Hg despite inotrope infusion \>30 minutes).

4. Other nonshockable rhythms (pulseless electric activity).

5. Terminal illness present before the OHCA.

6. Possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident).

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
32º Celsius	Endovascular Cooling	Endovascular Cooling was set at a target temperature of 32°C
34º Celsius	Endovascular Cooling	Endovascular Cooling was set at a target temperature of 32°C

Primary Outcome Measures

Name	Time	Method
Survival free from severe dependence (Barthel index <60)	6 months

Secondary Outcome Measures

Name	Time	Method
Survival at 6 months	6 months
Barthel Index at 6 months	6 months
Life threatening arrhythmias in different hypothermia temperatures	48 hours (during hypothermia)	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.)
Impact on ventricular function of different hypothermia temperatures	48 hours During hypothermia	Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function

Trial Locations

Locations (1)

Intensive Cardiac Care Unit. Hospital Universitario la Paz; 🇪🇸 Madrid, Spain