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Completed

NCT Number: NCT00843297

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

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Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Hypothermia Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig, Heart Center, Cardiology

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coolgard

Device

invasive Cooling via femoral ICY-catheter

ArcticSun

Device

Noninvasive surface-cooling by saline-cooled thermo-vest

conventional treatment

Other

Intensive care-treatment without cooling

Primary outcomes

  1. Time to reach the target temperature

    Time frame: Twenty-four hours

  2. NSE as a parameter for cerebral damage

    Time frame: Seventy-two hours

Secondary outcomes

  1. Neurologic outcome

    Time frame: Six months

  2. Survival

    Time frame: Six months

  3. Periprocedural complications

    Time frame: Seventy-two hours

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Acronym: COOL

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 13, 2009
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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