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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloprost | Active Comparator |
| |
| control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost | Drug | Iloprost nebulized |
| |
| control |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rosenberger, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42110435 | Derived | Bernard A, Serna-Higuita LM, Althaus K, Rosenberger P, Vohringer R, Korner A, Haeberle H, Eggstein C, Bakchoul T, Margraf A, Fodi C, Zarbock A, Koeppen M, Mirakaj V. Diminished plasma levels of GPIb-alpha predict mortality in a prospective ARDS cohort. Front Med (Lausanne). 2026 Apr 24;13:1711751. doi: 10.3389/fmed.2026.1711751. eCollection 2026. | |
| 36805707 |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Drug |
sodium chloride 0,9% nebulized |
|
| 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 |
| Haeberle HA, Calov S, Martus P, Serna-Higuita LM, Koeppen M, Goll A, Bernard A, Zarbock A, Meersch M, Weiss R, Mehrlander M, Marx G, Putensen C, Bakchoul T, Magunia H, Nieswandt B, Mirakaj V, Rosenberger P. Inhaled prostacyclin therapy in the acute respiratory distress syndrome: a randomized controlled multicenter trial. Respir Res. 2023 Feb 18;24(1):58. doi: 10.1186/s12931-023-02346-0. |
| 32131881 | Derived | Haeberle H, Prohaska S, Martus P, Straub A, Zarbock A, Marx G, Zago M, Giera M, Koeppen M, Rosenberger P. Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study. Trials. 2020 Mar 4;21(1):242. doi: 10.1186/s13063-020-4163-0. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |