Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study (MEMO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lean Body Mass
• Intervention / Treatment: Other: exposure(s) of interest : intensive care unit

Detailed Description

The study hypothesis is that a low muscle mass at ICU admission, measured at the level of L3 on CT scans performed for clinical routine, and its change over the ICU stay predict the prognosis of the patient, especially the 30-day mortality, that it may at least be partly counteracted by nutritional support and that it is related with higher ICU and hospital costs.

The objectives of this retrospective study are to determine:

1. the link between baseline body composition at ICU admission and outcomes, such as 30-day, ICU and hospital mortality and LOS, and infections. If this is confirmed, we aim to evaluate the added values of body composition to ICU severity scores to predict 30-day mortality
2. the link between baseline body composition vs. other locations to predict outcomes
3. the impact of body composition changes on the afore-mentioned outcomes. If this is confirmed, we aim to evaluate the added value of changes in body composition to changes in ICU severity scores to predict 30-day mortality
4. the impact of nutritional support on body composition changes

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Laurence Genton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of baseline body composition at ICU admission with other outcomes	Association of Skeletal muscle area (SMA), SMAH (Skeletal muscle area/height), SMD (Skeletal muscle density), IMAT (intermuscular and intramuscular adipose tissue), visceral and subcutaneous adipose tissue at the L3 vertebra level with 30-day mortality Determination of cut-off points of SMI, by sex, below which there is an increased risk of 30-day mortality Added value of body composition to ICU severity scores to predict 30-day mortality Association of baseline SMI, SMA, SMAH, SMD, intermuscular, visceral and subcutaneous adipose tissue at the L3 level, with ICU and hospital mortality and LOS, 30-day ICU readmission, duration of mechanical ventilation and infections	30-day
Association of baseline SMI at the L3 vertebra level vs. other locations to predict outcomes	Associations of SMI at the L3 vertebra level with SMI at the other locations Associations of SMI at the other locations with ICU and hospital mortality and LOS, 30-day ICU readmission, duration of mechanical ventilation and infections Comparison of the associations between muscle mass measured at the different anatomical locations and mortality in order to determine the best prognostic location	Day 1 to day 30
Association of body composition changes with outcomes	Association of changes in SMI, SMA, SMAH, SMD, IMAT, visceral and subcutaneous adipose tissue with 30-day mortality, ICU and hospital mortality and LOS, 30-day ICU readmission, duration of mechanical ventilation and infections Added value of changes in body composition to changes in ICU severity scores to predict 30-day mortality	Day 30
Association of body composition changes with nutritional support	Association of changes in energy coverage and changes in body composition Association of changes in protein coverage and changes in body composition	Day 30
Association of muscle loss with medico-economical parameters	Association of baseline muscle mass and muscle loss in the ICU with ICU and hospital costs Association of muscle loss in the ICU with level of nursing workload	Day 30

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: VBertoniMaluf
• Investigators: Principal Investigator: Laurence Genton, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intensive care unit; Muscle mass; Tomography; Skeletal muscle area; Third lumbar
• Other Study ID Numbers: 2022-01773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD Sharing Plan Description has not been decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No