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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Internal Cooling
* Device: External Cooling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External Cooling<br>The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature. | Device: External Cooling<br>* The gel-coated external cooling device consists of four water circulating gel coated energy transfer pads, and is placed on the patient's back, abdomen, and both thighs. Depending on the size used, the total surface area ranges between 0.60 and 0.77 m2. It is connected to an automatic thermostat controlling the temperature of the circulating water (4°C to 42°C) based on the patient's core temperature.<br>* Other names: Arctic Sun;|
| Active Comparator: Internal Cooling<br>The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature. | Device: Internal Cooling<br>* The intravascular cooling system uses a single lumen (8.5 Fr,38 cm) central venous catheter inserted into the inferior vena cava via the left or right femoral vein. Normal saline is pumped through three balloons mounted on the catheter and returned to a central system in a closed loop. The saline flow within the balloons is in close contact with the patient's blood flow and serves as a heat exchange system. An automatic temperature control device adjusts the temperature of the circulating saline (4°C to 42°C) based on the patient's core temperature.<br>* Other names: Alsius Thermogard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to hospital discharge |  | 30 days post arrest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological status of post-resuscitation patients |  | 1 year post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Internal cooling, External cooling, Cardiac arrest