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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
University Hospital Tuebingen
Tübingen, Germany
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)
Time frame: Day 6 of Study
Overall survival in 90-day follow-up period
90 day all cause mortality
Time frame: 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
Time frame: until ICU discharge, estimated average = 14 days
Duration of Mechanical Ventilation
Ventilation Support length
Time frame: 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.
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with Pulmonary Hemorrhage
Significant Bleeding from Lung
Time frame: until ICU discharge, estimated average = 14 days
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Number of Patients with Gastrointestinal Hemorrhage
Significant Bleeding from GI Tract
Time frame: 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
Time frame: 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.
Time frame: until ICU discharge, estimated average = 14 days
Number of Patients with ICU Acquired Weakness
Skeletal muscle dysfunction
Time frame: 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.
Time frame: 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.
Time frame: at 6 months after study inclusion