Time-differentiated Therapeutic Hypothermia

Out of Hospital Cardiac Arrest Clinical Trial

— TTH48  

Official title:

Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689077
• Other study ID #: TTH48
• Status: Completed
• Phase: N/A
• First received: September 17, 2012
• Last updated: January 17, 2017
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: December 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of Intensive Care, Erasme Hospital	Brussels
Denmark	Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg	Aalborg
Denmark	Department og Anesthesiologi and Intensive Care Medicine,	Aarhus
Denmark	Department of Cardiology, Copenhagen University Hospital, Rigshospitalet	Copenhagen
Denmark	Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital	Odense
Estonia	Anaesthesiology Clinic, North Estonia Medical Centre	Tallinn
Finland	Division of Anaesthesiology and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital	Helsinki
Finland	Hospital District of Southwest Finland), Kiinamyllynkatu	Turku
Germany	Department of Internal Medicine, Nephrology and Intensive Care; Charité-Universitätsmedizin Berlin	Berlin
Norway	Anesthesiology and Critical Care, Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Countries where clinical trial is conducted

Belgium,  Denmark,  Estonia,  Finland,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	GCS	Glasgow Coma Score at day 4 and at discharge from primary hospital unit	28 days
Other	GCS progression	Glasgow Coma Score throughout the observation period	25 weeks
Primary	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.	6 month
Secondary	Adverse events	Adverse events are registered during the treatment and until discharge from primary hospital unit	10 days
Secondary	CPC at discharge	CPC at discharge from primary hospital unit and after 28 days plus after 3 month	3 month
Secondary	Mortality	CPC 5 at 6 month	6 month