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

Purpose

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	Intervention	Phase
Non-environmental Hypothermia Cardiac Arrest	Procedure: Endovascular Cooling	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia Cardiac Arrest Hypothermia

U.S. FDA Resources

Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:

Survival free from severe dependence (Barthel index <60) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Barthel Index at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Life threatening arrhythmias in different hypothermia temperatures [ Time Frame: 48 hours (during hypothermia) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 48 hours During hypothermia ] [ Designated as safety issue: Yes ]
Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function

Enrollment:	36
Study Start Date:	March 2008
Study Completion Date:	May 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155622

Locations

Spain
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid, Spain, 28046

Sponsors and Collaborators

Hospital Universitario La Paz

Investigators

Principal Investigator:

Esteban Lopez-de-Sa, MD, FESC

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

More Information

Publications:

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 Nov 6. [Epub ahead of print]

Responsible Party:	Esteban Lopez de Sa Areses, MD, FESC, Hospital Universitario La Paz
ClinicalTrials.gov Identifier:	NCT01155622 History of Changes
Other Study ID Numbers:	Hypothermia_32vs34
Study First Received:	July 1, 2010
Last Updated:	December 4, 2012
Health Authority:	Spain: Ethics Committee

Keywords provided by Hospital Universitario La Paz:

Hypothermia, induced
Cardiac arrest
Disability evaluation
Cardiac arrhythmia

Ventricular function
Internal cooling
Out-of-hospital cardiac arrest
Post-cardiac arrest syndrome

Additional relevant MeSH terms:

Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases

Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013