Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection (MUSCOV)

October 21, 2022 updated by: Centre Hospitalier Universitaire Dijon

Sarcopenia is a risk factor for adverse outcome in critically ill patients. Sarcopenia might be estimated from muscle surface measure on tomodensitometry.

The purpose of the study is to identify if muscle surfaces measured on thoracic tomodensitometry are associated with mortality in patients with acute respiratory distress syndrome due to SARS-Cov-2.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with acute respiratory syndrome due to SARS-Cov-2

Description

Inclusion Criteria:

  • patients hospitalized in intensive care for SARS-Cov-2 infection since january 2020
  • Thoracic TDM within the 30 day preceding ICU admission and up to 24 hours after ICU admission

Exclusion Criteria:

  • Pregnancy
  • Neuromuscular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
28-day survival
Alive 28 days after intensive care admission
Other: Data collection

Demographic data:

Age, Sex, weight, height, main history and treatments.

- Biological data: CRP, PCT, albumin, pre-albumin

Other: analysis of thoracic scans
muscle area calculated on the T7 and T12 thoracic slices
28-day death
Deceased 28 days after intensive care admission
Other: Data collection

Demographic data:

Age, Sex, weight, height, main history and treatments.

- Biological data: CRP, PCT, albumin, pre-albumin

Other: analysis of thoracic scans
muscle area calculated on the T7 and T12 thoracic slices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of muscle area at T7 level indexed in cm²/m².
Time Frame: At hospital admission
use of CT measurements to discriminate between the 2 groups (deceased versus alive)
At hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of mechanical ventilation
Time Frame: within the 28 days
within the 28 days
Ventilator free days
Time Frame: within the 28 days
within the 28 days
number of days in Intensive care unit
Time Frame: within the 28 days
within the 28 days
number of days in hospital
Time Frame: within the 28 days
within the 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGUYEN 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrom (SARS-Cov 2)

Clinical Trials on Data collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe