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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00843297
Acronym
COOL
Enrollment
120
Registered
2009-02-13
Start date
2008-04-30
Completion date
2010-01-31
Last updated
2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Hypothermia

Keywords

Sudden Cardiac Arrest, Hypothermia, Outcome, neurological, Coolgard, ArcticSun

Brief summary

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

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.

Interventions

DEVICECoolgard

invasive Cooling via femoral ICY-catheter

DEVICEArcticSun

Noninvasive surface-cooling by saline-cooled thermo-vest

OTHERConventional treatment

Intensive care-treatment without cooling

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to reach the target temperatureTwenty-four hours
NSE as a parameter for cerebral damageSeventy-two hours

Secondary

MeasureTime frame
Neurologic outcomeSix months
SurvivalSix months
Periprocedural complicationsSeventy-two hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026