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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

January 22, 2009

Start Date ^†

October 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00827957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

A Prospective Clinical Study Comparing Controlled Therapeutic Hypothermia Post-Cardiac Arrest Using External and Internal Cooling to Standard Intensive Care Unit Therapy

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Cardiac Arrest With ROSC for 30 Minutes

Intervention ^†

Device: Internal Device (Alsius Thermogard)
Device: External Device (Arctic Sun)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

September 2010

Estimated Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

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.
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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Marcus EH Ong, MD

65 6321 3590

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

Location Countries ^†

Singapore

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827957

Responsible Party

Marcus Ong EH, Singapore General Hospital

Secondary IDs ^††

Study Sponsor ^†

Singapore General Hospital

Collaborators ^††

National Heart Centre, Singapore

Investigators ^†

Principal Investigator:

Marcus EH Ong, MBBS, MPH

Singapore General Hospital

Information Provided By

Singapore General Hospital

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.