NCT07329530

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
36mo left

Started Dec 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025Apr 2029

Study Start

First participant enrolled

December 1, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

December 12, 2025

Last Update Submit

January 8, 2026

Conditions

Critical IllnessMajor Abdominal Surgeries

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Health-related 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

    3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients

  • Health-related quality of life

    3 months after ICU discharge in the critically ill patients, or 3 months after the surgery in surgical patients

Study Arms (2)

ICU patients

EXPERIMENTAL

Lab and clinical investigations to characterize the metabolic and muscle profile

Diagnostic Test: Inflammation markersDiagnostic Test: Blood nucleosomesDiagnostic Test: Erythrocyte membrane fatty acid contentDiagnostic Test: measurement of myokinesDiagnostic Test: Resting energy expendureDiagnostic Test: body compositionDiagnostic Test: OmicsDiagnostic Test: Monocyte profile

Surgical patients

ACTIVE COMPARATOR

Lab and clinical investigations to characterize the metabolic and muscle profile

Diagnostic Test: Inflammation markersDiagnostic Test: Blood nucleosomesDiagnostic Test: Erythrocyte membrane fatty acid contentDiagnostic Test: measurement of myokinesDiagnostic Test: Resting energy expendureDiagnostic Test: body compositionDiagnostic Test: OmicsDiagnostic Test: Monocyte profile

Interventions

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)

ICU patientsSurgical patients
OmicsDIAGNOSTIC_TEST

Blood metabolic, lipidomic, proteomic study during the first 7 days after ICU admission (or the day after surgery)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients
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)

ICU patientsSurgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sart Tilman

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

Body Composition

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaMetabolismBody ConstitutionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 9, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

BE(1)