ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

Completed

• Conditions: Covid19

• Registration Number: NCT04522310
• Lead Sponsor: Centre Hospitalier de Lens

Brief Summary

COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Primary Completion: 2021-02-28
• Study Completion: 2021-05-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Any adult patient admitted in the ICU with COVID-19 pneumonia

Exclusion Criteria

• Pregnancy
• Legal reasons (patients under guardianship, curatorship)
• Patient's refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mortality at day 28 and day 90.	admission until day 90	mortality at day 28 and day 90.
Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.	comparison to day 1 and day 3	Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.

Secondary Outcome Measures

Name	Time	Method
Association between MR-ProADM and mortality at day 28.	admission until day 28	Association between MR-ProADM and mortality at day 28.
Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28.	admission until day 28	Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28.

Trial Locations

Locations (8)

Hospital of Arras; 🇫🇷 Arras, France

Hospital of Dunkerque; 🇫🇷 Dunkerque, France

Hospital of Boulogne/mer; 🇫🇷 Boulogne-sur-Mer, France

Hospital of DOUAI; 🇫🇷 Douai, France

Hospital Dr Schaffner; 🇫🇷 Lens, France

Hospital of Tourcoing; 🇫🇷 Tourcoing, France

Hospitalier of Valenciennes; 🇫🇷 Valenciennes, France

Hospital of Roubaix; 🇫🇷 Roubaix, France