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

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155622
• Other study ID #: Hypothermia_32vs34
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: December 4, 2012
• Start date: March 2008
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia
• Non-environmental Hypothermia
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Spain	Intensive Cardiac Care Unit. Hospital Universitario la Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Lopez-de-Sa E, Rey JR, Armada E, Salinas P, Viana-Tejedor A, Espinosa-Garcia S, Martinez-Moreno M, Corral E, Lopez-Sendon J. Hypothermia in comatose survivors from out-of-hospital cardiac arrest: pilot trial comparing 2 levels of target temperature. Circu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival free from severe dependence (Barthel index <60)		6 months	No
Secondary	Survival at 6 months		6 months	No
Secondary	Barthel Index at 6 months		6 months	No
Secondary	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)	Yes
Secondary	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	Yes