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NCT Number: NCT01155622

Trial of Different Hypothermia Temperatures in Patients Recovered From 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.

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Key information

Conditions

Non-environmental Hypothermia Arrhythmias, Cardiac Body Temperature Changes Brain Diseases Brain Injuries Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Heart Arrest Heart Diseases Hypothermia Nervous System Diseases Out-of-Hospital Cardiac Arrest Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Cardiac Arrest Syndrome Postoperative Complications Reperfusion Injury Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive Cardiac Care Unit. Hospital Universitario la Paz

Madrid, 28046, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular Cooling

Procedure

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.

Primary outcomes

  1. Survival free from severe dependence (Barthel index <60)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2010
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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