search
Back to results

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

Primary Purpose

Non-environmental Hypothermia, Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Endovascular Cooling
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-environmental Hypothermia focused on measuring Hypothermia, induced, Cardiac arrest, Disability evaluation, Cardiac arrhythmia, Ventricular function, Internal cooling, Out-of-hospital cardiac arrest, Post-cardiac arrest syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Cardiac Care Unit. Hospital Universitario la Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

32º Celsius

34º Celsius

Arm Description

Endovascular Cooling was set at a target temperature of 32°C

Endovascular Cooling was set at a target temperature of 32°C

Outcomes

Primary Outcome Measures

Survival free from severe dependence (Barthel index <60)

Secondary Outcome Measures

Survival at 6 months
Barthel Index at 6 months
Life threatening arrhythmias in different hypothermia temperatures
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
Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function

Full Information

First Posted
July 1, 2010
Last Updated
December 4, 2012
Sponsor
Hospital Universitario La Paz
search

1. Study Identification

Unique Protocol Identification Number
NCT01155622
Brief Title
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-environmental Hypothermia, Cardiac Arrest
Keywords
Hypothermia, induced, Cardiac arrest, Disability evaluation, Cardiac arrhythmia, Ventricular function, Internal cooling, Out-of-hospital cardiac arrest, Post-cardiac arrest syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
32º Celsius
Arm Type
Active Comparator
Arm Description
Endovascular Cooling was set at a target temperature of 32°C
Arm Title
34º Celsius
Arm Type
Active Comparator
Arm Description
Endovascular Cooling was set at a target temperature of 32°C
Intervention Type
Procedure
Intervention Name(s)
Endovascular Cooling
Intervention Description
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 Outcome Measure Information:
Title
Survival free from severe dependence (Barthel index <60)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Survival at 6 months
Time Frame
6 months
Title
Barthel Index at 6 months
Time Frame
6 months
Title
Life threatening arrhythmias in different hypothermia temperatures
Description
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.)
Time Frame
48 hours (during hypothermia)
Title
Impact on ventricular function of different hypothermia temperatures
Description
Echocardiographic evaluation of possible impact of different hypothermia temperatures on ventricular diastolic and systolic function
Time Frame
48 hours During hypothermia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esteban Lopez-de-Sa, MD, FESC
Organizational Affiliation
Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Cardiac Care Unit. Hospital Universitario la Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23136160
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs