Overview

Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure

Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in up to a total of 380 patients with septic shock suffering from organ failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in septic shock patients suffering from organ failure caused by endothelial breakdown, ultimately improving survival.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jakob Stensballe, MD, PhD
Collaborators:
Independent Research Fund Denmark
Innovation Fund Denmark
Treatments:
Epoprostenol
Iloprost
Tezosentan
Criteria
Inclusion Criteria:

All the following criteria must be fulfilled:

1. Adult intensive care patients (age ≥ 18 years)

2. Septic shock defined according to the Sepsis-3 criteria:

- suspected or documented infection

- persisting hypotension requiring vasopressors to maintain a mean arterial blood
pressure of 65 mmHg or above

- Lactate level of 2 mmol/L or above despite fluid therapy within the last 3 hours
at screening

3. Soluble thrombomodulin (sTM) above 10 ng/mL

Exclusion Criteria:

Patients who fulfil any of the following criteria will be excluded:

1. Withdrawal from active therapy

2. Pregnancy

3. Known hypersensitivity to iloprost.

4. Life-threatening bleeding as defined by the treating physician

5. Known severe heart failure (New York Heart Association (NYHA) class IV)

6. Suspected acute coronary syndrome

7. Previously included in this trial

8. Septic shock for more than 12 hours at the time of screening

9. Informed consent cannot be obtained

10. Included in other clinical trials with prostacyclin within 90 days