NCT01155622

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-environmental Hypothermia
• Cardiac Arrest

Interventions

Type	Name	Description
PROCEDURE	Endovascular Cooling	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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2010-07-02
• Last updated: 2012-12-05

Locations

1 site across 1 country: Spain