Respiratory Distress Syndrome, Adult
Conditions
Keywords
Acute respiratory distress syndrome
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.
Interventions
DRUGIloprost
Iloprost nebulized
DRUGcontrol
sodium chloride 0,9% nebulized
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of Mechanical Ventilation | until ICU discharge, estimated average = 14 days | Ventilation Support length |
| 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. |
| 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 |
| Overall survival in 90-day follow-up period | on day 90 after randomization and study entry | 90 day all cause mortality |
| 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. |
| 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 |
Countries
Germany
Outcome results
None listed