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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
Sponsor:
Information provided by (Responsible Party):
Esteban Lopez de Sa Areses, Hospital Universitario La Paz

Study Description
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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

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Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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Spain
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
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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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Publications of Results:

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Responsible Party: Esteban Lopez de Sa Areses, MD, FESC, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01155622    
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:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Hypothermia
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms