Efficacy and safety of 72-hours infusion of prostacyclin (1 ng/kg/min) in patients with septic shock suffering from organ failure caused by endothelial breakdow

Phase 1

• Conditions: Shock-induced endotheliopathy in patients with septic shock; MedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001131-31-DK
• Lead Sponsor: Section for transfusion Medicines, Capital Region Blood Bank, Copenhagen University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Adult intensive care patients (age = 18 years)
2. Septic shock, defined as (i) suspected or documented infection, (ii) persisting hypotension requiring vasopressors to maintain MAP =65 mm Hg AND a lactate level >2 mmol/L despite fluid therapy
3. sTM > 10 ng/mL

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Withdrawal from active therapy
2. Pregnancy (non-pregnancy confirmed by patient having a negative urine- or plasma hCG or being postmenopausal defined as females at 60 years old and beyond or at the investigators discretion)
3. Known hypersensitivity to iloprost or to any of the other ingredients.
4. Life-threatening bleeding as defined by the treating physician
5. Known severe heart failure (NYHA class IV)
6. Suspected acute coronary syndrome
7. Previously included in this trial
8. Screening > 12 hours after diagnosis of septic shock
9. Informed consent cannot be obtained
10. Included in clinical trials with prostacyclin within the last 90 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective in this trial is to investigate whether continuous infusion of iloprost at a dose of 1 ng/kg/min for 72-hours is safe and significantly reduce organ failure score in the ICU compared to infusion of placebo in patients with septic shock and SHINE.;Secondary Objective: Not applicable;Primary end point(s): Mean daily modified Sequential Organ Failure Assessment (SOFA) score, involving respiration-, coagulation-, liver-, cardiovascular- and renal function in the intensive care unit up to day 90 (scores for each of five systems range from 0 to 4, with higher scores indicating more severe dysfunction; the maximum score is 20) ;Timepoint(s) of evaluation of this end point: Day 90

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • 28 and 90-day mortality <br>• Vasopressor-free days in the ICU within 90 days<br>• Ventilator-free days in the ICU within 90 days<br>• Renal replacement free days in the ICU within 90 days<br>• Numbers of serious adverse reactions within the first 7 days<br>• Numbers of serious adverse events within the first 7 days (SAE is defined as ischaemic events and bleeding events (defined as requiring > 2 RBCs within 24 hours or ongoing bleeding)).<br>;Timepoint(s) of evaluation of this end point: Day 7, 28 and 90