Comparing Therapeutic Hypothermia Using External and Internal Cooling for Post-Cardiac Arrest Patients
This study is currently recruiting participants.
Verified December 2012 by Singapore General Hospital
Sponsor:
Singapore General Hospital
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: December 12, 2012
Last verified: December 2012
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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 Device (Alsius Thermogard) Device: External Device (Arctic Sun) |
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 Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post-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 ]
| Estimated Enrollment: | 51 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Surface Cooling |
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.
Other Name: Arctic Sun
|
| Active Comparator: Internal Cooling |
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.
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:
- 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
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 | |
| Sub-Investigator: Huck Chin Chew, MBBS | |
| Sub-Investigator: Juliana Poh, 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 of Singapore Pte Ltd
Investigators
| Principal Investigator: | Marcus EH Ong, MBBS, MPH | Singapore General Hospital |
More Information
No publications provided
| Responsible Party: | Ong Eng Hock Marcus, Senior Consultant, Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00827957 History of Changes |
| Other Study ID Numbers: | 2008/080/C |
| Study First Received: | January 21, 2009 |
| Last Updated: | December 12, 2012 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by Singapore General Hospital:
|
Hypothermia Internal cooling External cooling Cardiac arrest |
Additional relevant MeSH terms:
|
Heart Arrest Hypothermia Heart Diseases |
Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013