Iloprost in Acute Respiratory Distress Syndrome

Phase 3

Completed

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Drug: Iloprost; Drug: control

• Registration Number: NCT03111212
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2019-06-25
• Primary Completion: 2021-05-14
• Status Verified: 2021-06
• Study Completion: 2021-08-14
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iloprost	Iloprost	-
control	control	-

Primary Outcome Measures

Name	Time	Method
Oxygenation Index on Day 5 of Prostacyclin Treatment measured as PaO2/FiO2	Day 6 of Study	partial pressure of oxygen in blood (PaO2), in millimeters of mercury divided by the fraction of oxygen in the inhaled air (FiO2)

Secondary Outcome Measures

Name	Time	Method
Number of Patients with Pulmonary Embolism	until ICU discharge, estimated average = 14 days	Blockage of an artery in the lungs by a embolus that has moved from elsewhere in the body to the lung
Overall survival in 90-day follow-up period	on day 90 after randomization and study entry	90 day all cause mortality
Sequential Organ Failure Assessment Score (SOFA Score)	until ICU discharge, estimated average = 14 days	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
Number of Patients with the Occurence of Barotrauma	until ICU discharge, estimated average = 14 days	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.
Duration of Mechanical Ventilation	until ICU discharge, estimated average = 14 days	Ventilation Support length
Number of Patients with Pulmonary Hemorrhage	until ICU discharge, estimated average = 14 days	Significant Bleeding from Lung
Number of Patients with Gastrointestinal Hemorrhage	until ICU discharge, estimated average = 14 days	Significant Bleeding from GI Tract
Number of Patients with Delirium	until ICU discharge, estimated average = 14 days	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.
Number of Patients with ICU Acquired Weakness	until ICU discharge, estimated average = 14 days	Skeletal muscle dysfunction
Discharge Location	until ICU discharge, estimated average = 14 days	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.
Barthel Index (BI)	at 6 months after study inclusion	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.

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany