Iloprost in Acute Respiratory Distress Syndrome

Respiratory Distress Syndrome, Adult Clinical Trial

— ThIlo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111212
• Other study ID #: ThIlo
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2019
• Est. completion date: August 14, 2021

Study information

• Verified date: June 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Iloprost
Iloprost nebulized
• control
sodium chloride 0,9% nebulized

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival in 90-day follow-up period	90 day all cause mortality	on day 90 after randomization and study entry
Secondary	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
Secondary	Duration of Mechanical Ventilation	Ventilation Support length	until ICU discharge, estimated average = 14 days
Secondary	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
Secondary	Number of Patients with Pulmonary Hemorrhage	Significant Bleeding from Lung	until ICU discharge, estimated average = 14 days
Secondary	Number of Patients with Gastrointestinal Hemorrhage	Significant Bleeding from GI Tract	until ICU discharge, estimated average = 14 days
Secondary	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
Secondary	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
Secondary	Number of Patients with ICU Acquired Weakness	Skeletal muscle dysfunction	until ICU discharge, estimated average = 14 days
Secondary	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
Secondary	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