Critical IllnessIM3SINCT07329530
Metabolic and Muscle Profile in ICU Survivors
A study testing Inflammation markers, Blood nucleosomes and Erythrocyte membrane fatty acid content in people with Critical Illness and Major Abdominal Surgeries, run by Anne-Françoise Rousseau at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Major Abdominal Surgeries
- What is being tested?
- Inflammation markers, Blood nucleosomes and Erythrocyte membrane fatty acid content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to 1 Apr 2029
- Phase
- Interventional
- 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
Who may be able to join
- Critical illness:
- anticipated ICU stay >= 7 days
- Major abdominal surgery
- elective surgery
Who cannot join
- Active malignancy
- Inherited metabolic disorder
- Known muscle disease
- Pregnancy
- Patient refusal
- Patient unable to express informed consent (dementia, confusion)
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Sart Tilman
Liège, 4000
Gwaelle Ducomble, 003243237495, gwaelle.ducomble@chuliege.be
Damien Wertz, MD
About this study
Official title: 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.
- Conditions
- Critical Illness, Major Abdominal Surgeries
- Being tested
- Inflammation markers, Blood nucleosomes, Erythrocyte membrane fatty acid content, measurement of myokines, Resting energy expendure
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammation markersDiagnostic test
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)
Blood nucleosomesDiagnostic test
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)
Erythrocyte membrane fatty acid contentDiagnostic test
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)
measurement of myokinesDiagnostic test
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)
Resting energy expendureDiagnostic test
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)
body compositionDiagnostic test
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)
OmicsDiagnostic test
Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)
Monocyte profileDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Experimental | Lab and clinical investigations to characterize the metabolic and muscle profile Receives: 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 |
| Surgical patients | Active comparator | Lab and clinical investigations to characterize the metabolic and muscle profile Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps strength
Quadriceps strength in Newton, measured using a handheld dynamometer (MicroFet)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne-Françoise Rousseau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne-Françoise Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329530
- Sponsor's protocol ID
- IM3SI
- Acronym
- IM3SI
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of the Inflammatory, Metabolic, and Mitochondrial Profiles in the Context of Post-Intensive Care Muscle Dysfunction
- ClinicalTrials.gov ID
- NCT07329530
- Acronym / sponsor ID
- IM3SI / IM3SI
- Conditions
- Critical Illness, Major Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anne-Françoise RousseauUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 9 Jan 2026 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU patients | Experimental | 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 profileLab and clinical investigations to characterize the metabolic and muscle profile |
| Surgical patients | Active comparator | 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 profileLab and clinical investigations to characterize the metabolic and muscle profile |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critical illness:
- anticipated ICU stay >= 7 days
- Major abdominal surgery
- elective surgery
Key exclusion criteria (9 listed)
- Active malignancy
- Inherited metabolic disorder
- Known muscle disease
- Pregnancy
- Patient refusal
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 |
|---|---|---|
| Inflammation markersmeasurement 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 | ICU patients, Surgical patients |
| Blood nucleosomesmeasurement 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 | ICU patients, Surgical patients |
| Erythrocyte membrane fatty acid contentassessment 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 | ICU patients, Surgical patients |
| measurement of myokinesmeasurement 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 | ICU patients, Surgical patients |
| Resting energy expendureassessment 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 | ICU patients, Surgical patients |
| body compositionassessment 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 | ICU patients, Surgical patients |
| OmicsBlood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery) | Diagnostic test | ICU patients, Surgical patients |
| Monocyte profileBlood 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) | Diagnostic test | ICU patients, Surgical patients |
Primary outcome
Quadriceps strength
Time frame: 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
Quadriceps strength in Newton, measured using a handheld dynamometer (MicroFet)
Handgrip strength
Time frame: 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
Hangrip strength in kg, measured young an handheld dynamometer (Jamar)
Muscle mass
Time frame: 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
Quadriceps muscle thickness assessed by ultrasound
Muscle mass
Time frame: 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 assessed using bioelectrical impedance analysis
Muscle mitochondrial function
Time frame: 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
Oxygraphy performed on a muscle sample
Muscle function
Time frame: 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
Transcriptomic analysis in muscle sample (muscle biopsy)
Physical function
Time frame: 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)
2-minute walking test
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 12 Jan 2026.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inflammation markers, Blood nucleosomes and Erythrocyte membrane fatty acid content in people with Critical Illness and Major Abdominal Surgeries, run by Anne-Françoise Rousseau at 1 site in Belgium.
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 9 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps strength (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2026.