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
  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:


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.

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).
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Body Temperature Changes
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014