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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:

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).

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Survival free from severe dependence (Barthel index <60) [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Survival at 6 months [ Time Frame: 6 months ]
2. Barthel Index at 6 months [ Time Frame: 6 months ]
3. 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.)
4. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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
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