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

Sponsor

Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT01155622

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-environmental Hypothermia Cardiac Arrest	Procedure: Endovascular Cooling	Phase 4

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:

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 32º Celsius Endovascular Cooling was set at a target temperature of 32°C	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.
Active Comparator: 34º Celsius Endovascular Cooling was set at a target temperature of 32°C	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.

Arm

Intervention/Treatment

Active Comparator: 32º Celsius

Endovascular Cooling was set at a target temperature of 32°C

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.

Active Comparator: 34º Celsius

Endovascular Cooling was set at a target temperature of 32°C

Procedure: Endovascular Cooling

Outcome Measures

Primary Outcome Measures

Survival free from severe dependence (Barthel index <60) [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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