Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
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ClinicalTrials.gov Identifier: NCT01155622 |
Recruitment Status
:
Completed
First Posted
: July 2, 2010
Last Update Posted
: December 5, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-environmental Hypothermia Cardiac Arrest | Procedure: Endovascular Cooling | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
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 : | March 2008 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | May 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 32º Celsius
Endovascular Cooling was set at a target temperature of 32°C
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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.
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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.
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- Survival free from severe dependence (Barthel index <60) [ Time Frame: 6 months ]
- Survival at 6 months [ Time Frame: 6 months ]
- Barthel Index at 6 months [ Time Frame: 6 months ]
- Life threatening arrhythmias in different hypothermia temperatures [ Time Frame: 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 [ Time Frame: 48 hours During hypothermia ]Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155622
Spain | |
Intensive Cardiac Care Unit. Hospital Universitario la Paz | |
Madrid, Spain, 28046 |
Principal Investigator: | Esteban Lopez-de-Sa, MD, FESC | Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz |
Publications of Results:
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 |
First Posted: | July 2, 2010 Key Record Dates |
Last Update Posted: | December 5, 2012 |
Last Verified: | December 2012 |
Keywords provided by Esteban Lopez de Sa Areses, 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 |