Metabolic and Muscle Profile in ICU Survivors (IM3SI)

Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction

More and more patients survive a critical illness requiring admission to the intensive care unit, but they may be left with sequelae that are independent of the initial pathology. From a physical standpoint, the most visible complication is intensive care unit-acquired muscle weakness. A major factor in the development and persistence of muscle dysfunction appears to be the inflammatory response and the neuroendocrine stress response triggered by the initial critical insult. Persistence of inflammation beyond ICU discharge has been demonstrated in several studies. In response to inflammation, there is also increased oxidative stress associated with mitochondrial dysfunction.

The objectives of the present study are therefore:

to determine whether the broad inflammatory and metabolic profile of patients who have survived an ICU stay can predict the trajectory of muscle performance over the three months following ICU discharge; to compare this profile and muscle performance with those of non-critically ill surgical patients who have undergone a standardized inflammatory stress of lower intensity than that associated with critical illness; to investigate mitochondrial function in skeletal striated muscle after ICU stay, in light of the inflammatory and metabolic profile; to assess whether abnormalities in mitochondrial function also affect tissues other than skeletal muscle, in particular circulating blood mononuclear cells.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Major Abdominal Surgeries
• Intervention / Treatment: Diagnostic test: Inflammation markers; Diagnostic test: Blood nucleosomes; Diagnostic test: Erythrocyte membrane fatty acid content; Diagnostic test: measurement of myokines; Diagnostic test: Resting energy expendure; Diagnostic test: body composition; Diagnostic test: Omics; Diagnostic test: Monocyte profile

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • Chu Sart Tilman
    • Contact: Gwaelle Ducomble; Phone Number: 003243237495; Email: gwaelle.ducomble@chuliege.be
    • Sub-Investigator: Damien Wertz, MD
    • Sub-Investigator: Bernard Lambermont, PhD
    • Sub-Investigator: Quentin Maloir, MD
    • Sub-Investigator: Grégory Minguet, PhD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria

• Critical illness:
• anticipated ICU stay >= 7 days
• Major abdominal surgery
• elective surgery

Exclusion Criteria:

• Active malignancy
• Inherited metabolic disorder
• Known muscle disease
• Pregnancy
• Patient refusal
• Patient unable to express informed consent (dementia, confusion)
• Known coagulation disorder (cirrhosis, genetic coagulopathy) or thrombocytopenia < 100,000/mm³ on the day of biopsy, anemia with hemoglobin < 9 g/dL on the day of biopsy, or treatment with anticoagulant agents (contraindication to muscle biopsies only)
• Pacemaker or other implanted electronic device (contraindication to bioelectrical impedance analysis only)
• Oxygen therapy (contraindication to indirect calorimetry during spontaneous ventilation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICU patients; Lab and clinical investigations to characterize the metabolic and muscle profile	Diagnostic test: Inflammation markers; measurement of CRP, cytokines, MPO, oxidative stress during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Blood nucleosomes; measurement of blood nucleosomes between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Erythrocyte membrane fatty acid content; assessment of Erythrocyte membrane fatty acid content between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: measurement of myokines; measurement of myokines between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Resting energy expendure; assessment of REE by indirect caloriometry during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: body composition; assessment of body composition by BIA during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Omics; Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery); Diagnostic test: Monocyte profile; Blood leukocyte and monocyte profiles and transcriptomic analysis between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)
Active Comparator: Surgical patients; Lab and clinical investigations to characterize the metabolic and muscle profile	Diagnostic test: Inflammation markers; measurement of CRP, cytokines, MPO, oxidative stress during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Blood nucleosomes; measurement of blood nucleosomes between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Erythrocyte membrane fatty acid content; assessment of Erythrocyte membrane fatty acid content between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: measurement of myokines; measurement of myokines between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Resting energy expendure; assessment of REE by indirect caloriometry during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: body composition; assessment of body composition by BIA during the first 7 days after ICU admission, between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge); Diagnostic test: Omics; Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery); Diagnostic test: Monocyte profile; Blood leukocyte and monocyte profiles and transcriptomic analysis between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps strength	Quadriceps strength in Newton, measured using a handheld dynamometer (MicroFet)	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Handgrip strength	Hangrip strength in kg, measured young an handheld dynamometer (Jamar)	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Muscle mass	Quadriceps muscle thickness assessed by ultrasound	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Muscle mass	Muscle mass assessed using bioelectrical impedance analysis	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or the day after the surgery and 3 months after the surgery in surgical patients
Muscle mitochondrial function	Oxygraphy performed on a muscle sample	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Muscle function	Transcriptomic analysis in muscle sample (muscle biopsy)	between 1 and 7 days after ICU discharge and 3 months after ICU discharge in the critically ill patients, or perioperatively and 3 months after the surgery in surgical patients
Physical function	2-minute walking test	between 1 and 7 days after ICU discharge and 3 months after ICU discharge (or the day after surgery and 3 months after hospital discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of life	EQ-5D-3L questionnaire (3-level version of the EuroQOL questionnaire, including EQ-5D descriptive system with higher score indicating worst quality of life and the EQ visual analogue scale ranging from 0 to 100, with higher score indicating best quality of life)	3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients
Autonomy for ADL	Barthel index, ranging from 0 to 100, with higher score indicating full independency for activities of daily living	3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients
Health-related quality of life	SARQOL questionnaire (Sarcopenia and Quality Of Life questionnaire) - short form, ranging from 0 to 100, with higher score indicating best quality of life	3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients

Collaborators and Investigators

• Sponsor: Anne-Françoise Rousseau

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Physiological Phenomena; Biochemical Phenomena; Chemical Phenomena; Body Constitution; Metabolism; Body Composition
• Other Study ID Numbers: IM3SI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No