Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study
Abstract Background Acute respiratory distress syndrome (ARDS) is caused by rapid-onset (within hours) acute inflammatory processes in lung tissue, and it is a life-threatening condition with high mortality. The treatment of ARDS to date is focused on the prevention of further iatrogenic damage of t...
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| Format: | Article |
| Language: | English |
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BMC
2020-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-4163-0 |
| _version_ | 1818158671690989568 |
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| author | Helene Haeberle Stefanie Prohaska Peter Martus Andreas Straub Alexander Zarbock Gernot Marx Manola Zago Martin Giera Michael Koeppen Peter Rosenberger |
| author_facet | Helene Haeberle Stefanie Prohaska Peter Martus Andreas Straub Alexander Zarbock Gernot Marx Manola Zago Martin Giera Michael Koeppen Peter Rosenberger |
| author_sort | Helene Haeberle |
| collection | DOAJ |
| description | Abstract Background Acute respiratory distress syndrome (ARDS) is caused by rapid-onset (within hours) acute inflammatory processes in lung tissue, and it is a life-threatening condition with high mortality. The treatment of ARDS to date is focused on the prevention of further iatrogenic damage of the lung rather than the treatment of the initial inflammatory process. Several preclinical studies have revealed a beneficial effect of iloprost on the control of pulmonary inflammation, and in a small number of patients with ARDS, iloprost treatment resulted in improved oxygenation. Therefore, we plan to conduct a large multicenter trial to evaluate the effect of iloprost on ARDS. Methods The Therapeutic Iloprost during ARDS trial (ThIlo trial) is a multicenter, randomized, single blinded, clinical phase II trial assessing the efficacy of inhaled iloprost for the prevention of the development and progression of ARDS in critically ill patients. One hundred fifty critically ill patients suffering from acute ARDS will be treated either by nebulized iloprost or NaCl 0.9% for 5 days. Blood samples will be drawn at defined time points to elucidate the serum levels of iloprost and inflammatory markers during treatment. Mechanical ventilation will be standardized. In follow-up visits at days 28 and 90 as well as 6 months after enrollment, functional status according to the Barthel Index and a health care-related questionnaire, and frailty (Vulnerable Elders Survey) will be evaluated. The primary endpoint is the improvement of oxygenation, defined as the ratio of PaO2/FiO2. Secondary endpoints include 90-day all-cause mortality, Sequential Organ Failure Assessment scores during the study period up to day 90, the duration of mechanical ventilation, the length of intensive care unit (ICU) stay, ventilator-associated pneumonia, delirium, ICU-acquired weakness, and discharge localization. The study will be conducted in three university ARDS centers in Germany. Discussion The results of the ThIlo trial will highlight the anti-inflammatory effect of iloprost on early inflammatory processes during ARDS, resulting in the improvement of outcome parameters in patients with ARDS. Trial registration EUDRA-CT: 2016-003168-37. Registered on 12 April 2017. ClinicalTrials.gov: NCT03111212. Registered on 4 June 2017. |
| first_indexed | 2024-12-11T15:33:48Z |
| format | Article |
| id | doaj.art-d7c451e3acc54bb3b68fc2d2a4ebaf2f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T15:33:48Z |
| publishDate | 2020-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d7c451e3acc54bb3b68fc2d2a4ebaf2f2022-12-22T01:00:00ZengBMCTrials1745-62152020-03-0121111110.1186/s13063-020-4163-0Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II studyHelene Haeberle0Stefanie Prohaska1Peter Martus2Andreas Straub3Alexander Zarbock4Gernot Marx5Manola Zago6Martin Giera7Michael Koeppen8Peter Rosenberger9Department of Anesthesiology and Intensive Care Medicine, University Hospital, Universitätsklinikum TübingenDepartment of Anesthesiology and Intensive Care Medicine, University Hospital, Universitätsklinikum TübingenInstitute for Clinical Epidemiology und Applied Biostatistics, Eberhard Karls UniversityDepartment of Anesthesiology and Intensive Care Medicine, University Hospital, Universitätsklinikum TübingenDepartment of Anesthesiology, Intensive Care Therapy and Pain Medicine, University Hospital MünsterDepartment of Intensive Care Medicine and Intermediate Care, University Hospital RWTH Aachen, Medical Faculty RWTH Aachen UniversityCenter for Clinical Studies, University HospitalCenter for Proteomics and Metabolomics, Leiden University Medical Center (LUMC)Department of Anesthesiology and Intensive Care Medicine, University Hospital, Universitätsklinikum TübingenDepartment of Anesthesiology and Intensive Care Medicine, University Hospital, Universitätsklinikum TübingenAbstract Background Acute respiratory distress syndrome (ARDS) is caused by rapid-onset (within hours) acute inflammatory processes in lung tissue, and it is a life-threatening condition with high mortality. The treatment of ARDS to date is focused on the prevention of further iatrogenic damage of the lung rather than the treatment of the initial inflammatory process. Several preclinical studies have revealed a beneficial effect of iloprost on the control of pulmonary inflammation, and in a small number of patients with ARDS, iloprost treatment resulted in improved oxygenation. Therefore, we plan to conduct a large multicenter trial to evaluate the effect of iloprost on ARDS. Methods The Therapeutic Iloprost during ARDS trial (ThIlo trial) is a multicenter, randomized, single blinded, clinical phase II trial assessing the efficacy of inhaled iloprost for the prevention of the development and progression of ARDS in critically ill patients. One hundred fifty critically ill patients suffering from acute ARDS will be treated either by nebulized iloprost or NaCl 0.9% for 5 days. Blood samples will be drawn at defined time points to elucidate the serum levels of iloprost and inflammatory markers during treatment. Mechanical ventilation will be standardized. In follow-up visits at days 28 and 90 as well as 6 months after enrollment, functional status according to the Barthel Index and a health care-related questionnaire, and frailty (Vulnerable Elders Survey) will be evaluated. The primary endpoint is the improvement of oxygenation, defined as the ratio of PaO2/FiO2. Secondary endpoints include 90-day all-cause mortality, Sequential Organ Failure Assessment scores during the study period up to day 90, the duration of mechanical ventilation, the length of intensive care unit (ICU) stay, ventilator-associated pneumonia, delirium, ICU-acquired weakness, and discharge localization. The study will be conducted in three university ARDS centers in Germany. Discussion The results of the ThIlo trial will highlight the anti-inflammatory effect of iloprost on early inflammatory processes during ARDS, resulting in the improvement of outcome parameters in patients with ARDS. Trial registration EUDRA-CT: 2016-003168-37. Registered on 12 April 2017. ClinicalTrials.gov: NCT03111212. Registered on 4 June 2017.http://link.springer.com/article/10.1186/s13063-020-4163-0ARDSIloprostInflammationIntensive careVentilation |
| spellingShingle | Helene Haeberle Stefanie Prohaska Peter Martus Andreas Straub Alexander Zarbock Gernot Marx Manola Zago Martin Giera Michael Koeppen Peter Rosenberger Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study Trials ARDS Iloprost Inflammation Intensive care Ventilation |
| title | Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study |
| title_full | Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study |
| title_fullStr | Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study |
| title_full_unstemmed | Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study |
| title_short | Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study |
| title_sort | therapeutic iloprost for the treatment of acute respiratory distress syndrome ards the thilo trial a prospective randomized multicenter phase ii study |
| topic | ARDS Iloprost Inflammation Intensive care Ventilation |
| url | http://link.springer.com/article/10.1186/s13063-020-4163-0 |
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