A Phased Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post Resuscitation After Cardiac Arrest Using External and Internal Cooling to Standard Intensive Care Unit Therapy
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cardiac Arrest
- Sponsor
- Singapore General Hospital
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- Survival to hospital discharge
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
- •Patients aged between 18 to 80 years.
- •Patients who are hemodynamically stable, with a systolic BP \> 90 mmHg with or without inotropic support.
- •Patients comatose or unresponsive post-resuscitation
Exclusion Criteria
- •Hypotension despite fluid and/or vasopressor support
- •Positive pregnancy test in women below 50 years
- •Premorbid status bedbound and uncommunicative
Outcomes
Primary Outcomes
Survival to hospital discharge
Time Frame: 30 days post arrest
Secondary Outcomes
- Neurological status of post-resuscitation patients(1 year post discharge)