Status:
COMPLETED
Trial of Different Hypothermia Temperatures in Patients Recovered From Out-of-hospital Cardiac Arrest
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Non-environmental Hypothermia
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 evi...
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 minut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01155622
Start Date
March 1 2008
End Date
May 1 2012
Last Update
December 5 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Intensive Cardiac Care Unit. Hospital Universitario la Paz
Madrid, Madrid, Spain, 28046