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

NCT04123444 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DRUG

Iloprost

Continuously infusion for 72 hours. treatment dose 1 ng/kg/min

DRUG

Isotonic saline

Continuously infusion for 72 hours.

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Independent Research Fund Denmark

    collaborator INDUSTRY

  • Jakob Stensballe, MD, PhD

    lead OTHER

Principal Investigators

  • Morten Bestle, MD, PhD · Nordsjaelands Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2022-06-28
Completion
2022-06-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123444 on ClinicalTrials.gov