Endothelial Dysfunction in Resuscitated Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neuromuscular Blockade for Post-Cardiac Arrest Care

NCT02260258

Cardiac Arrest

COMPLETED PHASE2

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

NCT04668859

Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

TERMINATED PHASE4

Packed Red Blood Cell Transfusion During Cardiac Arrest

NCT06462027

Cardiac Arrest

RECRUITING PHASE1

Blood Gas Analysis and Buffering In Cardiac Arrest

NCT01362556

Cardiac Arrest

COMPLETED NA

Post-CA Neuroprotection With Magnesium

NCT06455514

Cardiac Arrest Return of Spontaneous Circulation

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Trial Rationale: Therapeutic interventions directed towards the damaged endothelium may improve outcome for patients with PCAS. Prostacyclin/Iloprost (PGI2) is an endogenous prostanoid which is formed and released by endothelial cells with anti-platelet, vasodilatory and cytoprotective properties36 and is expected to be beneficial by protecting and deactivating the endothelium and by restoring vascular integrity in patients suffering from endothelial breakdown.

Trial Population: Participants in the trial must be adult patients (≥18 years of age) with out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause admitted to the Dept. of Cardiology, 2143, Rigshospitalet, Copenhagen.

Trial Design: Randomized, placebo controlled, double-blind investigator-initiated trial in 40 OHCA patients. 48 hours of active study drug (Iloprost, 1 ng/kg/min) versus placebo (saline) infusion.

Patients in both randomization groups will be treated in accordance with state-of-the art therapy including targeted temperature management. Interventions are considered emergency procedures and study drug infusion should be commenced as soon as possible after sustained return of spontaneous circulation (ROSC), screening and randomization.

Patients will only be enrolled after informed consent, but as the treatment has to be initiated earliest possible after the out of hospital cardiac arrest diagnosis i.e., at a time-point where patients are temporarily incompetent, scientific guardians will co-sign the informed consent form before inclusion. Next-of-kin and the patients' general practitioner will co-sign as soon as possible and the patient will provide informed consent whenever possible.

During the study, blood samples will be taken at different time points. Patients will be observed and assessed continuously with regards to complications including bleeding. Patients will be actively assessed as long as the patient is in the ICU. During the extended follow up period at day 30, 90 and 180 contact will be made with the patients to follow up on safety events and vital status.

The trial is conducted in accordance with the protocol and is approved by Danish health and medicines authority, Danish ethics committee and danish data protection agency.

Investigational product: The active treatment in the trial is 1 ng/kg/min Ilomedin® administered as a 48h continuous i.v infusion. The drugs will be administered according to the product specifications.

Placebo: The placebo is 0.9% saline administered as a 48h continuous i.v infusion. The i.v volume of placebo saline to be administered is equal to the administered volume of diluted (in 0.9% saline) active drug.

Sponsor of study and financial support: This research project is investigator-initiated by the trial Sponsor Pär I. Johansson in collaboration with the principal investigator Christian Hassager.

It has not received funding from any commercial sponsors.

Patient recruitment period runs from February 2016 to August 2016. Follow-up data on 30-day, 90-day and 180-day outcome and adverse events will be collected. Initial data analyses will be done after completion of 30-day follow-up for all patients. Secondary data analyses will be done after completion of 180-day follow-up for all patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Iloprost + M1006B offset by -10 mmHg

Administration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg

Intervention: Drug: Iloprost + M1006B offset -10mmHg

Group Type EXPERIMENTAL

Iloprost

Intervention Type DRUG

Phillips M1006B, offset by -10mmHg

Intervention Type DEVICE

Administration of blood pressure module M1006B: offset by -10 mmHg

Iloprost + M1006B, No offset

Administration of 1 ng/kg/min Ilomedin® as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset

Intervention: Drug: Iloprost + M1006B, No offset

Group Type EXPERIMENTAL

Iloprost

Intervention Type DRUG

Philips M1006B, No offset

Intervention Type DEVICE

Administration of blood pressure module M1006B: No offset

Placebo + M1006B offset by -10 mmHg

Double dummy 0.9% saline as a 48h continuous i.v infusion. Administration of blood pressure modules M1006B: offset by -10 mmHg

Intervention: Drug: Placebo + M1006B offset -10mmHg

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Phillips M1006B, offset by -10mmHg

Intervention Type DEVICE

Administration of blood pressure module M1006B: offset by -10 mmHg

Placebo + M1006B, No offset

Double dummy 0.9% saline as a 48h continuous i.v infusion Administration of blood pressure modules M1006B: No offset

Intervention: Drug: Placebo + M1006B, No offset

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Philips M1006B, No offset

Intervention Type DEVICE

Administration of blood pressure module M1006B: No offset

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Iloprost

Intervention Type DRUG

Saline

Intervention Type DRUG

Phillips M1006B, offset by -10mmHg

Administration of blood pressure module M1006B: offset by -10 mmHg

Intervention Type DEVICE

Philips M1006B, No offset

Administration of blood pressure module M1006B: No offset

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ilomedin (R) Prostacyclin analogue (PGI2) 0,9% NaCl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No