Out of Hospital Cardiac Arrest
Conditions
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.
Interventions
Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| GCS | 28 days | Glasgow Coma Score at day 4 and at discharge from primary hospital unit |
| GCS progression | 25 weeks | Glasgow Coma Score throughout the observation period |
Countries
Belgium, Denmark, Estonia, Finland, Germany, Norway
Outcome results
None listed