Iloprost in Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress Syndrome, Adult

Intervention / Treatment
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* Drug: Iloprost
* Drug: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iloprost<br> | Drug: Iloprost<br>* Iloprost nebulized<br>|
| Placebo Comparator: control<br> | Drug: control<br>* sodium chloride 0,9% nebulized<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory distress syndrome