Time-differentiated Therapeutic Hypothermia

Not Applicable

Completed

• Conditions: Out of Hospital Cardiac Arrest
• Interventions: Other: Therapeutic hypothermia

• Registration Number: NCT01689077
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.

Detailed Description

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH-CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-20
• Study Start: 2013-01
• Status Verified: 2016-12
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

1. Out of hospital cardiac arrest of suspected cardiac origin
2. Return of spontaneous circulation (ROSC)
3. Glasgow Coma Score < 8
4. Estimated time interval from cardiac arrest to ROSC ≤ 60 min

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Exclusion Criteria

1. OOH-CA of suspected origin other than cardiac
2. In hospital Cardiac arrest
3. Terminal disease
4. Coagulation disorders
5. Unwitnessed asystolia
6. Time from cardiac arrest to start of hypothermia treatment > 240 min
7. GCS ≥ 8
8. Pregnancy
9. Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump).
10. CPC 3-4 before cardiac arrest
11. Acute intra cerebral bleeding
12. Acute stroke
13. Acute coronary artery bypass grafting

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
48 hours hypothermoa	Therapeutic hypothermia	48 hours hypothermia
24 hours hypothermia	Therapeutic hypothermia	24 hours hypothermia

Primary Outcome Measures

Name	Time	Method
CPC	6 month	CPC = Cerebral Performance Category Score. The primary outcome of the study is analyzed as the proportion of patients with good neurological outcome in the two groups, (CPC 1-2) at 6 months after CA.

Secondary Outcome Measures

Name	Time	Method
Adverse events	10 days	Adverse events are registered during the treatment and until discharge from primary hospital unit
CPC at discharge	3 month	CPC at discharge from primary hospital unit and after 28 days plus after 3 month
Mortality	6 month	CPC 5 at 6 month

Trial Locations

Locations (10)

Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Department of Intensive Care, Erasme Hospital; 🇧🇪 Brussels, Belgium

Anaesthesiology Clinic, North Estonia Medical Centre; 🇪🇪 Tallinn, Estonia

Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Hospital District of Southwest Finland), Kiinamyllynkatu; 🇫🇮 Turku, Finland

Anesthesiology and Critical Care, Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg; 🇩🇰 Aalborg, Denmark

Department og Anesthesiologi and Intensive Care Medicine,; 🇩🇰 Aarhus, Denmark

Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark