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

Sponsors and Collaborators:	Singapore General Hospital National Heart Centre, Singapore
Information provided by:	Singapore General Hospital
ClinicalTrials.gov Identifier:	NCT00827957

Purpose

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.

Condition	Intervention	Phase
Cardiac Arrest With ROSC for 30 Minutes	Device: Internal Device (Alsius Thermogard) Device: External Device (Arctic Sun)	Phase IV

MedlinePlus related topics: Hypothermia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post-Cardiac Arrest Using External and Internal Cooling to Standard Intensive Care Unit Therapy

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:

Survival to hospital discharge [ Time Frame: 30 days post arrest ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurological status of post-resuscitation patients [ Time Frame: 1 year post discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	51
Study Start Date:	October 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Internal Device (Alsius Thermogard) 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.
2: Active Comparator	Device: External Device (Arctic Sun) 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.

Arms

Assigned Interventions

1: Active Comparator

Device: Internal Device (Alsius Thermogard)

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.

2: Active Comparator

Device: External Device (Arctic Sun)

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min
Patients aged between 18 to 80 years.
Females aged below 50 years with a negative pregnancy test
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, and/or
Females aged below 50 years with a negative pregnancy test
Premorbid status bedbound and uncommunicative

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827957

Contacts

Contact: Marcus EH Ong, MD

65 6321 3590

marcus.ong.e.h@sgh.com.sg

Locations

Singapore
Singapore General Hospital	Recruiting
Singapore, Singapore, 169608
Contact: Marcus EH Ong, MBBS,MPH 65 63213590 marcus.ong.e.h@sgh.com.sg
Principal Investigator: Marcus EH Ong, MBBS,MPH
Sub-Investigator: Eng Koon Lim, MBBS
National Heart Centre	Recruiting
Singapore, Singapore, 168752
Contact: Aaron SL Wong, MBBS 65 64367531
Sub-Investigator: Aaron SL Wong, MBBS

Sponsors and Collaborators

Singapore General Hospital

National Heart Centre, Singapore

Investigators

Principal Investigator:

Marcus EH Ong, MBBS, MPH

Singapore General Hospital

More Information

No publications provided

Responsible Party:	Singapore General Hospital ( Marcus Ong EH )
Study ID Numbers:	#134/2008
Study First Received:	January 21, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827957 History of Changes
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:

Hypothermia
Internal cooling
External cooling
Cardiac arrest

Study placed in the following topic categories:

Signs and Symptoms
Hypothermia
Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Signs and Symptoms
Hypothermia
Heart Diseases

Cardiovascular Diseases
Heart Arrest
Body Temperature Changes

ClinicalTrials.gov processed this record on May 06, 2009