Clinical trial NCT05834894: Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study
Official title: Does Muscle Mass At Intensive Care Unit Admission Determine Mortality: the Memo Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lean Body Mass
Keywords: Muscle mass
Skeletal muscle area
Third lumbar
Tomography
Intensive care unit
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: VBertoniMaluf
First posted: 2023-04-28
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 30-day mortality
timeFrame: 30-day mortality between January 1st 2010 and December 31st 2022.
Secondary outcomes:
measure: Association of baseline body composition at ICU admission with other outcomes
timeFrame: 30-day
measure: Association of baseline SMI at the L3 vertebra level vs. other locations to predict outcomes
timeFrame: Day 1 to day 30
measure: Association of body composition changes with outcomes
timeFrame: Day 30
measure: Association of body composition changes with nutritional support
timeFrame: Day 30
measure: Association of muscle loss with medico-economical parameters
timeFrame: Day 30
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Laurence Genton
Study officials:
affiliation: University Hospital, Geneva
name: Laurence Genton, MD
role: PRINCIPAL_INVESTIGATOR
References: