Endothelial Dysfunction in Resuscitated Cardiac Arrest

• Status: Completed
• Trial end date: 2017-02-27
• Target enrollment: 0
• Participant gender: All

Summary

Objective: Safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac-arrest-syndrome (PCAS) patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pär Johansson
• Treatments: Epoprostenol; Iloprost; Tezosentan

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. OHCA of presumed cardiac cause

3. Sustained ROSC*

4. Unconsciousness (GCS <8) (patients not able to obey verbal commands) after sustained ROSC*

5. Target temperature management is indicated.

Exclusion Criteria:

1. Conscious patients (obeying verbal commands)

2. Females of childbearing potential (unless a negative human chorionic gonadotropin (HCG) test can rule out pregnancy within the inclusion window)

3. Patients weighing more than 135kg

4. In-hospital cardiac arrest (IHCA)

5. OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).

6. Known congenital bleeding diathesis (medically induced coagulopathy due to treatment with Vitamin K antagonists, Thrombininhibitors, Factor Xa inihbitors, ADP-receptor inhibitors, Aspirin, Asasantin, Persantin, NSAID, unfractionated and low molecular weight heparin does NOT exclude the patient).

7. Suspected or confirmed acute intracranial bleeding

8. Suspected or confirmed acute stroke

9. Unwitnessed asystole

10. Known limitations in therapy and Do Not Resuscitate-order

11. Known disease making 180 days survival unlikely

12. Known pre-arrest CPC 3 or 4

13. >4 hours (240 minutes) from ROSC to screening

14. Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device*

15. Temperature on admission <30°C.

16. Known allergy to Prostacyclin analogues