COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest (COOL)

February 1, 2010 updated by: University of Leipzig

Clinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig, Heart Center, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ROSC after SCA due to VF/VT or PEA/Asystolia
  • GCS 3

Exclusion Criteria:

  • Non-cardiac SCA
  • Pregnancy
  • Unstable Circulation instead of High-dose Inotropics
  • Life-expectancy reducing concomitant illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CG
Coolgard: invasive Cooling
Device: Coolgard
invasive Cooling via femoral ICY-catheter
Active Comparator: AS
ArcticSun: Surface-Cooling
Device: ArcticSun
Noninvasive surface-cooling by saline-cooled thermo-vest
Sham Comparator: UnCOOL
No Cooling-Therapy due to non-operational cooling-devices
Other: Conventional treatment
Intensive care-treatment without cooling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to reach the target temperature
Time Frame: Twenty-four hours
Twenty-four hours
NSE as a parameter for cerebral damage
Time Frame: Seventy-two hours
Seventy-two hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurologic outcome
Time Frame: Six months
Six months
Survival
Time Frame: Six months
Six months
Periprocedural complications
Time Frame: Seventy-two hours
Seventy-two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Holger Thiele, Associate Professor, Study Chair
  • Study Director: Undine Pittl, MD, Study Sub-Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COOL-Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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