Clinical trial NCT03111212: Iloprost in Acute Respiratory Distress Syndrome
Official title: Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Acute respiratory distress syndrome
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2
timeFrame: Day 6 of Study
Secondary outcomes:
measure: Overall survival in 90-day follow-up period
timeFrame: on day 90 after randomization and study entry
measure: Sequential Organ Failure Assessment Score (SOFA Score)
timeFrame: until ICU discharge, estimated average = 14 days
measure: Duration of Mechanical Ventilation
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with the Occurence of Barotrauma
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with Pulmonary Hemorrhage
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with Gastrointestinal Hemorrhage
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with Pulmonary Embolism
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with Delirium
timeFrame: until ICU discharge, estimated average = 14 days
measure: Number of Patients with ICU Acquired Weakness
timeFrame: until ICU discharge, estimated average = 14 days
measure: Discharge Location
timeFrame: until ICU discharge, estimated average = 14 days
measure: Barthel Index (BI)
timeFrame: at 6 months after study inclusion
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Peter Rosenberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.