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Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients

Phase 4
Completed
Conditions
Cardiac Arrest
Registration Number
NCT00827957
Lead Sponsor
Singapore General Hospital
Brief Summary

Controlled therapeutic hypothermia is a method of preserving neurological function post-resuscitation.It has been associated with improved functional recovery and reduced histological deficits in animal models of cardiac arrest.

Detailed Description

Three randomized clinical studies have been reported showing improved neurological outcome and reduced mortality in post-resuscitation patients treated with hypothermia compared to controls. Of the various methods of inducing hypothermia, internal cooling using an endovascular catheter and external cooling using gel pads with a water based circulating system have shown the most promise. There have not been any studies looking at outcomes between the two methods of cooling.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
51
Inclusion Criteria
  1. Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
  2. Patients aged between 18 to 80 years.
  3. Patients who are hemodynamically stable, with a systolic BP > 90 mmHg with or without inotropic support.
  4. Patients comatose or unresponsive post-resuscitation
Exclusion Criteria
  1. Hypotension despite fluid and/or vasopressor support
  2. Positive pregnancy test in women below 50 years
  3. Premorbid status bedbound and uncommunicative

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Survival to hospital discharge30 days post arrest
Secondary Outcome Measures
NameTimeMethod
Neurological status of post-resuscitation patients1 year post discharge

Trial Locations

Locations (2)

National Heart Centre Singapore

πŸ‡ΈπŸ‡¬

Singapore, Singapore

Singapore General Hospital

πŸ‡ΈπŸ‡¬

Singapore, Singapore

National Heart Centre Singapore
πŸ‡ΈπŸ‡¬Singapore, Singapore

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