Acute Respiratory Distress Syndrom (SARS-Cov 2)MUSCOVNCT05594550
Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection
An observational study of Acute Respiratory Distress Syndrom (SARS-Cov 2), run by Centre Hospitalier Universitaire Dijon.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrom (SARS-Cov 2)
- What is being tested?
- Data collection and analysis of thoracic scans
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with acute respiratory syndrome due to SARS-Cov-2
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Neuromuscular disease
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Data collection, analysis of thoracic scans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Demographic data:
Age, Sex, weight, height, main history and treatments.
- Biological data: CRP, PCT, albumin, pre-albumin
analysis of thoracic scansOther
muscle area calculated on the T7 and T12 thoracic slices
| Study group | Role | What they receive |
|---|---|---|
| 28-day survival | Alive 28 days after intensive care admission Receives: Other: Data collection; Other: analysis of thoracic scans | |
| 28-day death | Deceased 28 days after intensive care admission Receives: Other: Data collection; Other: analysis of thoracic scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of muscle area at T7 level indexed in cm²/m².
use of CT measurements to discriminate between the 2 groups (deceased versus alive)
Measured: At hospital admission
Secondary outcomes (4)
Duration of mechanical ventilation
Measured: within the 28 days
Ventilator free days
Measured: within the 28 days
number of days in Intensive care unit
Measured: within the 28 days
number of days in hospital
Measured: within the 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrom (SARS-Cov 2)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594550
- Sponsor's protocol ID
- NGUYEN 2022
- Acronym
- MUSCOV
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of T7 and T12 Slices on Mortality in Resuscitation Patients With ARDS Caused by SARS-COV2 Infection
- ClinicalTrials.gov ID
- NCT05594550
- Acronym / sponsor ID
- MUSCOV / NGUYEN 2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28-day survival | – | Other: Data collection, Other: analysis of thoracic scansAlive 28 days after intensive care admission |
| 28-day death | – | Other: Data collection, Other: analysis of thoracic scansDeceased 28 days after intensive care admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with acute respiratory syndrome due to SARS-Cov-2
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionDemographic data: Age, Sex, weight, height, main history and treatments. - Biological data: CRP, PCT, albumin, pre-albumin | Other | 28-day death, 28-day survival |
| analysis of thoracic scansmuscle area calculated on the T7 and T12 thoracic slices | Other | 28-day death, 28-day survival |
Primary outcome
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)
4 secondary outcomes
Duration of mechanical ventilation
Time frame: within the 28 days
Ventilator free days
Time frame: within the 28 days
number of days in Intensive care unit
Time frame: within the 28 days
number of days in hospital
Time frame: within the 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrom (SARS-Cov 2), run by Centre Hospitalier Universitaire Dijon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxime NGUYEN (380293528 ext. +33, maxime.nguyen-soenen@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of muscle area at T7 level indexed in cm²/m². (time frame: At hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.