NCT05834894

Brief Summary

This retrospective monocentric study aims to investigate whether a low muscle mass at ICU admission and its loss over the ICU stay predicts mortality, and in what proportion we can counteract it by nutritional support.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

15.4 years

First QC Date

April 17, 2023

Last Update Submit

December 3, 2024

Conditions

Keywords

Muscle massSkeletal muscle areaThird lumbarTomographyIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    Association between skeletal muscle index (SMI) at the L3 vertebra level (psoas + abdominal wall muscles + paraspinal muscles), measured from 48 hours before to 96 hours after ICU admission, with 30-day mortality.

    30-day mortality between January 1st 2010 and December 31st 2022.

Secondary Outcomes (5)

  • Association of baseline body composition at ICU admission with other outcomes

    30-day

  • Association of baseline SMI at the L3 vertebra level vs. other locations to predict outcomes

    Day 1 to day 30

  • Association of body composition changes with outcomes

    Day 30

  • Association of body composition changes with nutritional support

    Day 30

  • Association of muscle loss with medico-economical parameters

    Day 30

Interventions

Low muscle mass is highly prevalent at hospital admission, and muscle mass generally decreases during hospital stay, especially in critically-ill patients. We would like to mesure muscle mas in critically ill patients and determine the association between outcomes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022

You may qualify if:

  • Associations of baseline body composition with clinical outcomes:
  • Adults ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022 and Abdominal, or thoraco-abdominal CT scan measured 48 hours before to 96 hours after ICU admission in the HUG
  • Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:
  • Identical as for the associations of baseline body composition with clinical outcomes and At least one additional CT performed during the hospital stay

You may not qualify if:

  • Associations of baseline body composition with clinical outcomes:
  • CT scans of low quality or CT scans performed outside of the HUG or Presence of a documented refusal
  • Associations of body composition changes with clinical outcomes, nutritional support or medico-economic paratemers:
  • Additionnally: oral nutrition, because we cannot assess the quantity and composition of oral intakes retrospectively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laurence Genton

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Genton L, Bertoni Maluf VA, Herrmann FR, Prado CM, de Watteville A, Dupertuis YM, Collet TH, Platon A, Heidegger CP. Obesity is associated with lower 30-day mortality in critically ill patients: A retrospective study of over 5400 patients. Clin Nutr ESPEN. 2025 Oct;69:37-44. doi: 10.1016/j.clnesp.2025.06.046. Epub 2025 Jun 30.

Study Officials

  • Laurence Genton, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

January 1, 2010

Primary Completion

May 31, 2025

Study Completion

October 31, 2025

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations