Iloprost in Acute Respiratory Distress Syndrome (ThIlo)

Therapeutic Iloprost for the Treatment of Acute Respiratory Distress Syndrome (ARDS) (the ThIlo-Trial)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Drug: Iloprost; Drug: control

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • University Hospital Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control	Drug: control; sodium chloride 0,9% nebulized
Active Comparator: Iloprost	Drug: Iloprost; Iloprost nebulized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival in 90-day follow-up period	90 day all cause mortality	on day 90 after randomization and study entry
Sequential Organ Failure Assessment Score (SOFA Score)	The SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is assessed by 0=normal function to max 4 points=severe organ dysfunction Lowest Score is 0, the Maximums Score is 24; high Scores mean worse outcome	until ICU discharge, estimated average = 14 days
Duration of Mechanical Ventilation	Ventilation Support length	until ICU discharge, estimated average = 14 days
Number of Patients with the Occurence of Barotrauma	Barotrauma is damage to body tissue secondary to pressure difference in enclosed cavities within the body.Ventilator asynchrony, acute elevation of the plateau and peak pressures above 30 cmH2O, or sudden decrease of delivered tidal volume are result of barotrauma.	until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Hemorrhage	Significant Bleeding from Lung	until ICU discharge, estimated average = 14 days
Number of Patients with Gastrointestinal Hemorrhage	Significant Bleeding from GI Tract	until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Embolism	Blockage of an artery in the lungs by a embolus that has moved from elsewhere in the body to the lung	until ICU discharge, estimated average = 14 days
Number of Patients with Delirium	An organically caused decline from a previous baseline mental functioning, that develops over a short period of time, typically hours to days. Measured as occurence and length in time.	until ICU discharge, estimated average = 14 days
Number of Patients with ICU Acquired Weakness	Skeletal muscle dysfunction	until ICU discharge, estimated average = 14 days
Discharge Location	Number of Patients discharged to home without additional care (self-care), home with additional care (home health care) and other care facilities such as nursing homes. Measured as % of patients discharged to either of these locations.	until ICU discharge, estimated average = 14 days
Barthel Index (BI)	Is a measure using an ordinal scale used to measure performance in activities of daily living (ADL). The original 10-item form of the BI consists of 10 common ADL activities including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Items are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent (scored as 10, 5 or 0). Items are weighted according to the level of nursing care required.	at 6 months after study inclusion

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): May 14, 2021
• Study Completion (Actual): August 14, 2021

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Acute respiratory distress syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Vasodilator Agents; Platelet Aggregation Inhibitors; Iloprost
• Other Study ID Numbers: ThIlo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No