Lean Body MassMEMONCT05834894
Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study
An observational study of Lean Body Mass, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lean Body Mass
- What is being tested?
- exposure(s) of interest : intensive care unit
- How many people
- 4,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2010to 31 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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
- the link between baseline body composition vs. other locations to predict outcomes
- 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
- the impact of nutritional support on body composition changes
- Conditions
- Lean Body Mass
- Being tested
- exposure(s) of interest : intensive care unit
- Keywords
- Muscle mass, Skeletal muscle area, Third lumbar, Tomography, Intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure(s) of interest : intensive care unitOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Jan 2010
- Primary completion31 May 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lean Body MassStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- VBertoniMaluf
- Responsible party
- Principal investigator, Genton Graf Laurence, University Hospital, Geneva
- Investigators
- Laurence Genton, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834894
- Sponsor's protocol ID
- 2022-01773
- Acronym
- MEMO
- Status last verified
- Dec 2024
- First submitted
- 17 Apr 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD Sharing Plan Description has not been decided.
Publications
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.
PubMed 40602605
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study
- ClinicalTrials.gov ID
- NCT05834894
- Acronym / sponsor ID
- MEMO / 2022-01773
- Conditions
- Lean Body Mass
- Keywords
- Muscle mass, Skeletal muscle area, Third lumbar, Tomography, Intensive care unit
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- VBertoniMaluf
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Apr 2023 (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.
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.
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:
- 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
- the link between baseline body composition vs. other locations to predict outcomes
- 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
- the impact of nutritional support on body composition changes
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ≥ 18 yrs, hospitalized in the ICU of the HUG between January 1st 2010 and December 31st 2022
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| exposure(s) of interest : intensive care unitLow 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. | Other | – |
Primary outcome
30-day mortality
Time frame: 30-day mortality between January 1st 2010 and December 31st 2022.
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.
5 secondary outcomes
Association of baseline body composition at ICU admission with other outcomes
Time frame: 30-day
Association of baseline SMI at the L3 vertebra level vs. other locations to predict outcomes
Time frame: Day 1 to day 30
Association of body composition changes with outcomes
Time frame: Day 30
Association of body composition changes with nutritional support
Time frame: Day 30
Association of muscle loss with medico-economical parameters
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 40602605Genton 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.
- Individual participant dataSharing planned: Undecided. IPD Sharing Plan Description has not been decided.
Related trials for Lean Body Mass
RecruitingPhase 2/3
Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
Type 1 Diabetes, Overweight , Obesity
Not yet recruiting
Yeast Protein Supplementation and Muscle Preservation During GLP-1RA-Induced Weight Loss
Overweight and Obesity in Adults Receiving GLP-1RA Treatment
RecruitingObservational study
Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
Pulmonary Hypertension
RecruitingObservational study
Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes
Obesity (Disorder), Type 2 Diabetes Mellitus
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
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.
Laurence Genton, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lean Body Mass, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30-day mortality between January 1st 2010 and December 31st 2022.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834894, which also lists 1 linked publication.
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 6 Dec 2024.