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

NCT ID: NCT01155622

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-05-31

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).

Conditions

Non-environmental Hypothermia; Cardiac Arrest

Keywords

Hypothermia, induced; Cardiac arrest; Disability evaluation; Cardiac arrhythmia; Ventricular function; Internal cooling; Out-of-hospital cardiac arrest; Post-cardiac arrest syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

32º Celsius

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

Group Type: ACTIVE_COMPARATOR

Endovascular Cooling

Intervention Type: PROCEDURE

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.

34º Celsius

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

Group Type: ACTIVE_COMPARATOR

Endovascular Cooling

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Esteban Lopez de Sa Areses

MD, FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esteban Lopez-de-Sa, MD, FESC

Role: PRINCIPAL_INVESTIGATOR

Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz

Locations

Intensive Cardiac Care Unit. Hospital Universitario la Paz

Madrid, Madrid, Spain

Countries

Spain

References

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. Circulation. 2012 Dec 11;126(24):2826-33. doi: 10.1161/CIRCULATIONAHA.112.136408. Epub 2012 Nov 6.

Reference Type: RESULT

PMID: 23136160 (View on PubMed)

Other Identifiers

Hypothermia_32vs34

Identifier Type: -

Identifier Source: org_study_id