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

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Internal Cooling
External Cooling
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Hypothermia, Internal cooling, External cooling, Cardiac arrest

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Heart Centre Singapore
  • Singapore General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

External Cooling

Internal Cooling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Survival to hospital discharge

Secondary Outcome Measures

Neurological status of post-resuscitation patients

Full Information

First Posted
January 21, 2009
Last Updated
February 9, 2017
Sponsor
Singapore General Hospital
Collaborators
National Heart Centre Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00827957
Brief Title
Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National Heart Centre Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Hypothermia, Internal cooling, External cooling, Cardiac arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Cooling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Internal Cooling
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Internal Cooling
Other Intervention Name(s)
Alsius Thermogard
Intervention Description
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 Type
Device
Intervention Name(s)
External Cooling
Other Intervention Name(s)
Arctic Sun
Intervention Description
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 Measure Information:
Title
Survival to hospital discharge
Time Frame
30 days post arrest
Secondary Outcome Measure Information:
Title
Neurological status of post-resuscitation patients
Time Frame
1 year post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sustained return of spontaneous circulation (ROSC) after cardiac arrest, for more than 30 min Patients aged between 18 to 80 years. 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 Positive pregnancy test in women below 50 years Premorbid status bedbound and uncommunicative
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus EH Ong, MBBS, MPH
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
168752
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
24188226
Citation
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.
Results Reference
derived

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

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