Metabolic and Muscle Profile in ICU Survivors

NCT ID: NCT07329530

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness Major Abdominal Surgeries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICU patients

Lab and clinical investigations to characterize the metabolic and muscle profile

Group Type EXPERIMENTAL

Monocyte profile

Intervention Type DIAGNOSTIC_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)

Resting energy expendure

Intervention Type DIAGNOSTIC_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 composition

Intervention Type DIAGNOSTIC_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)

Omics

Intervention Type DIAGNOSTIC_TEST

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

Inflammation markers

Intervention Type DIAGNOSTIC_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 nucleosomes

Intervention Type DIAGNOSTIC_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 content

Intervention Type DIAGNOSTIC_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 myokines

Intervention Type DIAGNOSTIC_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)

Surgical patients

Lab and clinical investigations to characterize the metabolic and muscle profile

Group Type ACTIVE_COMPARATOR

Monocyte profile

Intervention Type DIAGNOSTIC_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)

Resting energy expendure

Intervention Type DIAGNOSTIC_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 composition

Intervention Type DIAGNOSTIC_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)

Omics

Intervention Type DIAGNOSTIC_TEST

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

Inflammation markers

Intervention Type DIAGNOSTIC_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 nucleosomes

Intervention Type DIAGNOSTIC_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 content

Intervention Type DIAGNOSTIC_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 myokines

Intervention Type DIAGNOSTIC_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)

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Omics

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

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anne-Françoise Rousseau

OTHER

Sponsor Role lead

Responsible Party

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Anne-Françoise Rousseau

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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CHU Sart Tilman

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Gwaelle Ducomble

Role: primary

003243237495

Other Identifiers

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IM3SI

Identifier Type: -

Identifier Source: org_study_id

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