NCT01155622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

4.1 years

First QC Date

July 1, 2010

Last Update Submit

December 4, 2012

Conditions

Non-environmental HypothermiaCardiac Arrest

Keywords

Hypothermia, inducedCardiac arrestDisability evaluationCardiac arrhythmiaVentricular functionInternal coolingOut-of-hospital cardiac arrestPost-cardiac arrest syndrome

Outcome Measures

Primary Outcomes (1)

  • Survival free from severe dependence (Barthel index <60)

    6 months

Secondary Outcomes (4)

  • Survival at 6 months

    6 months

  • Barthel Index at 6 months

    6 months

  • Life threatening arrhythmias in different hypothermia temperatures

    48 hours (during hypothermia)

  • Impact on ventricular function of different hypothermia temperatures

    48 hours During hypothermia

Study Arms (2)

32º Celsius

ACTIVE COMPARATOR

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

Procedure: Endovascular Cooling

34º Celsius

ACTIVE COMPARATOR

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

Procedure: Endovascular Cooling

Interventions

Endovascular CoolingPROCEDURE

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.

32º Celsius34º Celsius

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Cardiac Care Unit. Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

  • 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.

    PMID: 23136160RESULT

MeSH Terms

Conditions

Heart ArrestHypothermiaArrhythmias, CardiacOut-of-Hospital Cardiac ArrestPost-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesReperfusion InjuryVascular DiseasesPostoperative Complications

Study Officials

  • Esteban Lopez-de-Sa, MD, FESC

    Intensive Cardiac Care Unit. Department of Cardiology. Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FESC

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 2, 2010

Study Start

March 1, 2008

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

ES(1)