Iloprost in Acute Respiratory Distress Syndrome

NCT03111212 | Completed Phase 3 DMC

• 1 other identifier: ThIlo
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The patients will be randomized into one of two groups. Both groups will receive standard care as is state of the art. The intervention group will receive Iloprost nebulized as inhalative therapy.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2

  partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)

  Day 6 of Study

Secondary Outcomes (11)

• Overall survival in 90-day follow-up period

  on day 90 after randomization and study entry

• Sequential Organ Failure Assessment Score (SOFA Score)

  until ICU discharge, estimated average = 14 days

• Duration of Mechanical Ventilation

  until ICU discharge, estimated average = 14 days

• Number of Patients with the Occurence of Barotrauma

  until ICU discharge, estimated average = 14 days

• Number of Patients with Pulmonary Hemorrhage

  until ICU discharge, estimated average = 14 days

Study Arms (2)

Iloprost

ACTIVE COMPARATOR

Drug: Iloprost

control

PLACEBO COMPARATOR

Drug: control

Interventions

Iloprost DRUG

Iloprost nebulized

Iloprost

control DRUG

sodium chloride 0,9% nebulized

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Horowitz index \<300
• Bilateral opacities on frontal chest radiograph
• requirement of positive pressure ventilation
• no clinical evidence of left atrial hypertension
• enrollment within 48h of onset of ARDS
• mechanical ventilation \<7 days

You may not qualify if:

• age \<18 years
• mechanical ventilation \>7 days
• patient, surrogate or physician not committed to full intensive care support
• pregnancy

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (2)

• Haeberle HA, Calov S, Martus P, Serna-Higuita LM, Koeppen M, Goll A, Bernard A, Zarbock A, Meersch M, Weiss R, Mehrlander M, Marx G, Putensen C, Bakchoul T, Magunia H, Nieswandt B, Mirakaj V, Rosenberger P. Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial. Respir Res. 2023 Feb 18;24(1):58. doi: 10.1186/s12931-023-02346-0.

  PMID: 36805707 DERIVED

• Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0.

  PMID: 32131881 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Peter Rosenberger, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: June 25, 2019
• Primary Completion: May 14, 2021
• Study Completion: August 14, 2021
• Last Updated: December 30, 2021

Record last verified: 2021-06

Locations

DE (1)