Iloprost in Acute Respiratory Distress Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT03111212
• Date of registration: 06/04/2017
• Prospective Registration: Yes
• Primary sponsor: University Hospital Tuebingen
• Public title: Iloprost in Acute Respiratory Distress Syndrome ThIlo
• Scientific title: Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
• Date of first enrolment: June 25, 2019
• Target sample size: 150
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03111212
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Peter Rosenberger, MD
• Affiliation: University Hospital Tuebingen

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- age <18 years

- mechanical ventilation >7 days

- patient, surrogate or physician not committed to full intensive care support

- pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Distress Syndrome, Adult

Intervention(s)

Drug: control

Drug: Iloprost

Primary Outcome(s)

Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2 [Time Frame: Day 6 of Study]

Secondary Outcome(s)

Number of Patients with ICU Acquired Weakness [Time Frame: until ICU discharge, estimated average = 14 days]

Discharge Location [Time Frame: until ICU discharge, estimated average = 14 days]

Number of Patients with Delirium [Time Frame: until ICU discharge, estimated average = 14 days]

Duration of Mechanical Ventilation [Time Frame: until ICU discharge, estimated average = 14 days]

Number of Patients with Pulmonary Embolism [Time Frame: until ICU discharge, estimated average = 14 days]

Number of Patients with Pulmonary Hemorrhage [Time Frame: until ICU discharge, estimated average = 14 days]

Number of Patients with the Occurence of Barotrauma [Time Frame: until ICU discharge, estimated average = 14 days]

Overall survival in 90-day follow-up period [Time Frame: on day 90 after randomization and study entry]

Number of Patients with Gastrointestinal Hemorrhage [Time Frame: until ICU discharge, estimated average = 14 days]

Sequential Organ Failure Assessment Score (SOFA Score) [Time Frame: until ICU discharge, estimated average = 14 days]

Secondary ID(s)

ThIlo

Source(s) of Monetary Support

Please refer to primary and secondary sponsors