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

NCT ID: NCT00843297

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrest Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CG

Coolgard: invasive Cooling

Group Type ACTIVE_COMPARATOR

Coolgard

Intervention Type DEVICE

invasive Cooling via femoral ICY-catheter

AS

ArcticSun: Surface-Cooling

Group Type ACTIVE_COMPARATOR

ArcticSun

Intervention Type DEVICE

Noninvasive surface-cooling by saline-cooled thermo-vest

UnCOOL

No Cooling-Therapy due to non-operational cooling-devices

Group Type SHAM_COMPARATOR

Conventional treatment

Intervention Type OTHER

Intensive care-treatment without cooling

Interventions

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Coolgard

invasive Cooling via femoral ICY-catheter

Intervention Type DEVICE

ArcticSun

Noninvasive surface-cooling by saline-cooled thermo-vest

Intervention Type DEVICE

Conventional treatment

Intensive care-treatment without cooling

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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University of Leipzig, Heart Center

Principal Investigators

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Holger Thiele, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Study Chair

Undine Pittl, MD

Role: STUDY_DIRECTOR

Study Sub-Investigator

Locations

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University of Leipzig, Heart Center, Cardiology

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Zeiner A, Holzer M, Sterz F, Behringer W, Schorkhuber W, Mullner M, Frass M, Siostrzonek P, Ratheiser K, Kaff A, Laggner AN. Mild resuscitative hypothermia to improve neurological outcome after cardiac arrest. A clinical feasibility trial. Hypothermia After Cardiac Arrest (HACA) Study Group. Stroke. 2000 Jan;31(1):86-94. doi: 10.1161/01.str.31.1.86.

Reference Type BACKGROUND
PMID: 10625721 (View on PubMed)

Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.

Reference Type BACKGROUND
PMID: 11856794 (View on PubMed)

Other Identifiers

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COOL-Trial

Identifier Type: -

Identifier Source: org_study_id

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