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

Cardiac Arrest Clinical Trial

— Hypothermia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827957
• Other study ID #: CIRB 2008/080/C
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2009
• Last updated: February 9, 2017
• Start date: October 2008
• Est. completion date: October 2014

Study information

• Verified date: February 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Hypothermia

Intervention

Device:
• 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
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.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to hospital discharge		30 days post arrest
Secondary	Neurological status of post-resuscitation patients		1 year post discharge