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Insufficient recruitment of eligible patients.
ProCoCo
Sponsor study identifier
Secondary identifiers
OTHER · AP-HM
NIH
interventional
21
1 country
1
Study Start
December 27, 2018
Actual (reported)Primary Completion
November 29, 2023
Actual (reported)Study Completion
November 29, 2023
Actual (reported)Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is associated with an increased mortality and prolonged lengths of mechanical ventilation, ICU stay and hospitalization. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of collagen. All of these pathways may be responsive to corticosteroid therapy. Only two randomized controlled double-blinded trials assessed the use of corticosteroids for persistent ARDS. In 24 patients, Meduri et al. reported an improvement of lung function and survival (1). In 180 patients, Steinberg et al showed no effect of corticosteroids on survival (2). A lower risk of death was observed when corticosteroids were started before 14 days after the onset of ARDS (2). Alveolar procollagen III is validated as a biomarker of active fibroproliferation. Alveolar procollagen III \> 9 µg/L is associated to fibroproliferation (3). As mortality was lower in patients who received corticosteroids while presenting a high alveolar level of procollagen III on inclusion, Steinberg et al. showed that patients presenting with a low level of procollagen III and treated with corticosteroids had an increased risk of death (2). Investigatores hypothesize that the use of procollagen III could improve personalized decision-making regarding steroid treatment in patients presenting with persistent ARDS. The future of anti-fibrotic treatment, including corticosteroids, in persistent ARDS might propose to individualize the therapy according to the presence of an active fibroproliferative phase (precision or personalized medicine).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 29, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2017
Actual (reported)December 13, 2017
Actual (reported)December 27, 2018
Actual (reported)November 29, 2023
Actual (reported)November 29, 2023
Actual (reported)Ventilator Free Days
Number of Ventilator Free Days to day 60
60 days
ICU and hospital mortality
90 days
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L will receive methylprednisolone
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L will receive placebo
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
Jean-Olivier ARNAUD
Assistance Publique Hôpitaux de Marseille
21 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2017
First Posted
December 13, 2017
Study Start
December 27, 2018
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 29, 2023
Actual (reported)Study Completion
November 29, 2023
Actual (reported)Last Updated
January 3, 2024
Record last verified: 2023-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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