Time-differentiated Therapeutic Hypothermia

University of Aarhus355 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

355

Conditions

Out of Hospital Cardiac Arrest

Interventions

Therapeutic hypothermiaOTHER

Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 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

Locations (10)

Department of Intensive Care, Erasme Hospital

Brussels, Belgium

Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg

Aalborg, Denmark

Department og Anesthesiologi and Intensive Care Medicine,

Aarhus, Denmark

Outcomes

Primary Outcomes

CPC

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.

Time frame: 6 month

Secondary Outcomes

Adverse events

Adverse events are registered during the treatment and until discharge from primary hospital unit

Time frame: 10 days

CPC at discharge

CPC at discharge from primary hospital unit and after 28 days plus after 3 month

Time frame: 3 month

Mortality

CPC 5 at 6 month

Time frame: 6 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.