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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esteban Lopez de Sa Areses, Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01155622
First received: July 1, 2010
Last updated: December 4, 2012
Last verified: December 2012

July 1, 2010
December 4, 2012
March 2008
April 2012   (final data collection date for primary outcome measure)
Survival free from severe dependence (Barthel index <60) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155622 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
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

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.

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).
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Non-environmental Hypothermia
  • Cardiac Arrest
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: 32º Celsius
    Endovascular Cooling was set at a target temperature of 32°C
    Intervention: Procedure: Endovascular Cooling
  • Active Comparator: 34º Celsius
    Endovascular Cooling was set at a target temperature of 32°C
    Intervention: Procedure: Endovascular Cooling
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]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
May 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01155622
Hypothermia_32vs34
No
Esteban Lopez de Sa Areses, Hospital Universitario La Paz
Hospital Universitario La Paz
Not Provided
Principal Investigator: Esteban Lopez-de-Sa, MD, FESC Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz
Hospital Universitario La Paz
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP