Cardiac Arrest Clinical Trial
— ENDO-RCAOfficial title:
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 Patients - a Randomized, Controlled, Double-blinded Investigator-initiated Trial.
Verified date | March 2021 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 27, 2017 |
Est. primary completion date | August 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Cardiology, 2143, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Pär Johansson |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients with severe bleeding | Severe bleeding (intracranial or clinical bleeding with the use of 3 red blood cells (RBC) units or more/24 hours) | 24 hours-180 days | |
Other | Number of patients requiring organ support | Days of vasopressor, ventilator and renal replacement therapy post-randomization. | 48 hours to 180 days | |
Other | Mean change in disease severity score | Changes in SOFA score from baseline to 48 h and day 4 post-randomization. | 48 to 96 hours | |
Other | Number of patients with transfusion requirements | Use of blood products (in ICU) post-randomization. | 48 hours to 180 days | |
Other | Grading of Neurological function. | Neurological function graded by modified Rankin Scale (mRS) and Cerebral Performance Category (CPC) at 180 days. | to 180 days | |
Other | Mortality | Difference in day 7, 30, 90 and 180 day mortality between patients receiving active treatment (lloprost) and placebo. | 24 hours to 180 days | |
Other | Evaluation of Renal function | Estimated glomerular filtration rate (eGFR) and urine output at day 2 and 3 and need for renal replacement therapy. | 24 to 96hours | |
Primary | Mean change i plasma biomarkers reflecting endothelial activation and damage | Mean change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, soluble thrombomodulin (sTM), soluble vascular endothelial growth factor (sVEGF), nucleosomes) and sympathoadrenal overactivation (epinephrine/norepinephrine) from baseline to 48 hours post-randomization. | 48 hours | |
Secondary | Mean change in hemostatic profile evaluated by TEG, Multiplate, Flowcytometry | Mean change in the hemostatic profile evaluated by Thrombelastography (TEG)(change in functional hemostatic blood test) and Multiplate (whole blood platelet aggregometry) and change in Flowcytometry (change in blood cell and endothelial cell derived microparticles). from baseline to 48 hours post-randomization. | 48 hours | |
Secondary | Blood pressure target influence on primary outcomes measured by mean change in plasma biomarkers. | Blood pressure target (65 mmHg or 75 mmHg) influence on the endothelial response to the study drug (mean change in biomarkers reflecting endothelial activation and damage) and change in levels of Neuron Specific Enolasis from baseline to 48 hours post-randomization. | 48 hours | |
Secondary | Feasibility of blood pressure target intervention. | Feasibility of blood pressure target intervention .(Target 90%) | 48 hours |
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