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 breakdown

“Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in patients with septic shock induced endotheliopathy – a multicentre randomized, placebo-controlled, blinded, investigator-initiated trial”

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001131-31-DK

Enrollment

380

Registered

2019-03-15

Start date

2019-06-25

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock-induced endotheliopathy in patients with septic shock MedDRA version: 23.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Ilomedin Product Name: Ilomedin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ILOPROST CAS Number: 78919-13-8 Concentration unit: µg/ml microgram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): • 28 and 90-day mortality • Vasopressor-free days in the ICU within 90 days • Ventilator-free days in the ICU within 90 days • Renal replacement free days in the ICU within 90 days • Numbers of serious adverse reactions within the first 7 days • 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)). ;Timepoint(s) of evaluation of this end point: Day 7, 28 and 90	—

Measure

Time frame

Secondary end point(s): • 28 and 90-day mortality • Vasopressor-free days in the ICU within 90 days • Ventilator-free days in the ICU within 90 days • Renal replacement free days in the ICU within 90 days • Numbers of serious adverse reactions within the first 7 days • 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)). ;Timepoint(s) of evaluation of this end point: Day 7, 28 and 90

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Countries

Denmark

Contacts

Public ContactKristine Pedersen

Section for transfusion Medicines, Capital Region Blood Bank, Copenhagen University Hospital

kristine.holst.pedersen.01@regionh.dk+4535453489

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026