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

Phase 4

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: Internal Cooling; Device: External Cooling

• 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-22
• Study First Posted: 2009-01-23
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

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

Arm && Interventions

Group	Intervention	Description
Internal Cooling	Internal Cooling	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.
External Cooling	External Cooling	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.

Primary Outcome Measures

Name	Time	Method
Survival to hospital discharge	30 days post arrest

Secondary Outcome Measures

Name	Time	Method
Neurological status of post-resuscitation patients	1 year post discharge

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore