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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Singapore General Hospital
Sponsor:
Collaborator:
National Heart Centre of Singapore Pte Ltd
Information provided by (Responsible Party):
Ong Eng Hock Marcus, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00827957
First received: January 21, 2009
Last updated: April 22, 2014
Last verified: April 2014

January 21, 2009
April 22, 2014
October 2008
May 2015   (final data collection date for primary outcome measure)
Survival to hospital discharge [ Time Frame: 30 days post arrest ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00827957 on ClinicalTrials.gov Archive Site
Neurological status of post-resuscitation patients [ Time Frame: 1 year post discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Arrest
  • 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.
    Other Name: Alsius Thermogard
  • Device: 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.
    Other Name: Arctic Sun
  • Active Comparator: 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.
    Intervention: Device: External Cooling
  • Active Comparator: 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.
    Intervention: Device: Internal Cooling
Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
August 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Marcus EH Ong, MD 65 6321 3590 marcus.ong.e.h@sgh.com.sg
Singapore
 
NCT00827957
CIRB 2008/080/C
No
Ong Eng Hock Marcus, Singapore General Hospital
Singapore General Hospital
National Heart Centre of Singapore Pte Ltd
Principal Investigator: Marcus EH Ong, MBBS, MPH Singapore General Hospital
Singapore General Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP