PIrfenidone to prevent fibrOsis in ARDS. A RaNdomizEd controllEd tRial - PIONEER

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Brief summary

The primary outcome of this clinical trial is to document an increase in the number of ventilator free days (VFD) at day 28 in the Pirfenidone group when compared to the placebo group.

Detailed description

Increase in ICU-free days at day 28, Increase in cumulative SOFA-free score at day 28, Reduction in hospital length of stay, Reduction in fibroproliferative changes on high-resolution CT performed at ICU discharge, according to specific interpretation guidelines, Mortality at ICU/hospital discharge, Better pulmonary function test (spirometry) at hospital discharge, Greater distance at the 6 minute walk test (at 6-12 months), Better Quality of life as measured by EQ-5D Health Questionnaire and SF-36 questionnaire, Right and left heart dysfunction as determined by echocardiography at ICU discharge, Adverse event rate, Use of rescue therapies for severe hypoxaemia

Related papers

No related papers found yet.

Interventions

DRUGSODIO CLORURO 0

DRUG9% BAXTER Soluzione per infusione

DRUGEsbriet 267 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome of this clinical trial is to document an increase in the number of ventilator free days (VFD) at day 28 in the Pirfenidone group when compared to the placebo group.	—

Secondary

Measure	Time frame
Increase in ICU-free days at day 28, Increase in cumulative SOFA-free score at day 28, Reduction in hospital length of stay, Reduction in fibroproliferative changes on high-resolution CT performed at ICU discharge, according to specific interpretation guidelines, Mortality at ICU/hospital discharge, Better pulmonary function test (spirometry) at hospital discharge, Greater distance at the 6 minute walk test (at 6-12 months), Better Quality of life as measured by EQ-5D Health Questionnaire and SF-36 questionnaire, Right and left heart dysfunction as determined by echocardiography at ICU discharge, Adverse event rate, Use of rescue therapies for severe hypoxaemia	—

Measure

Time frame

Increase in ICU-free days at day 28, Increase in cumulative SOFA-free score at day 28, Reduction in hospital length of stay, Reduction in fibroproliferative changes on high-resolution CT performed at ICU discharge, according to specific interpretation guidelines, Mortality at ICU/hospital discharge, Better pulmonary function test (spirometry) at hospital discharge, Greater distance at the 6 minute walk test (at 6-12 months), Better Quality of life as measured by EQ-5D Health Questionnaire and SF-36 questionnaire, Right and left heart dysfunction as determined by echocardiography at ICU discharge, Adverse event rate, Use of rescue therapies for severe hypoxaemia

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Countries

Italy

Outcome results

None listed