Status:
COMPLETED
Infusion of Prostacyclin (Iloprost) vs Placebo for 72-hours in Patients With Septic Shock Suffering From Organ Failure
Lead Sponsor:
Jakob Stensballe, MD, PhD
Collaborating Sponsors:
Innovation Fund Denmark
Independent Research Fund Denmark
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 sep...
Detailed Description
Patients with the most severe type of sepsis, those with septic shock have a mortality rate between 30% to 45% due to multiple organ failure. The poor outcome of shocked patients, and especially those...
Eligibility Criteria
Inclusion
- All the following criteria must be fulfilled:
- Adult intensive care patients (age ≥ 18 years)
- 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
- Soluble thrombomodulin (sTM) above 10 ng/mL
Exclusion
- Patients who fulfil any of the following criteria will be excluded:
- Withdrawal from active therapy
- Pregnancy
- Known hypersensitivity to iloprost.
- Life-threatening bleeding as defined by the treating physician
- Known severe heart failure (New York Heart Association (NYHA) class IV)
- Suspected acute coronary syndrome
- Previously included in this trial
- Septic shock for more than 12 hours at the time of screening
- Informed consent cannot be obtained
- Included in other clinical trials with prostacyclin within 90 days
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04123444
Start Date
October 30 2019
End Date
June 28 2022
Last Update
May 7 2024
Active Locations (6)
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1
Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark
2
Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
3
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, Denmark
4
Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital
Hillerød, Denmark