Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Coolgard

+ ArcticSun

+ Conventional treatment

DeviceOther
Who is being recruted

Body Temperature Changes+10

+ Cardiovascular Diseases

+ Death

+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: April 2008
See protocol details

Summary

Principal SponsorUniversity of Leipzig
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleClinical and Neurological Outcome With Two Different Cooling Methods (Invasive and Non-invasive) After Sudden Cardiac Arrest
NCT00843297
Principal SponsorUniversity of Leipzig
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body Temperature ChangesCardiovascular DiseasesDeathDeath, SuddenHeart ArrestHeart DiseasesHypothermiaNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDeath, Sudden, Cardiac

Criteria

2 inclusion criteria required to participate
ROSC after SCA due to VF/VT or PEA/Asystolia
GCS 3
4 exclusion criteria prevent from participating
Non-cardiac SCA
Pregnancy
Unstable Circulation instead of High-dose Inotropics
Life-expectancy reducing concomitant illness

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Coolgard: invasive Cooling

Group II

Active Comparator
ArcticSun: Surface-Cooling

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Leipzig, Heart Center, Cardiology

Leipzig, GermanyOpen University of Leipzig, Heart Center, Cardiology in Google Maps
CompletedOne Study Center