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

This study has been completed.
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: November 19, 2014
Last verified: November 2014
  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
Device: Internal Cooling
Device: External Cooling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 51
Study Start Date: October 2008
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
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

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Singapore
National Heart Centre Singapore
Singapore, Singapore, 168752
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
National Heart Centre of Singapore Pte Ltd
Investigators
Principal Investigator: Marcus EH Ong, MBBS, MPH Singapore General Hospital
  More Information

No publications provided by Singapore General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ong Eng Hock Marcus, Senior Consultant, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00827957     History of Changes
Other Study ID Numbers: CIRB 2008/080/C
Study First Received: January 21, 2009
Last Updated: November 19, 2014
Health Authority: Singapore: Institutional Review Board

Keywords provided by Singapore General Hospital:
Hypothermia
Internal cooling
External cooling
Cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Body Temperature Changes
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014