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Skeletal Muscle Wasting in ICU Patients

NCT ID: NCT06234826

Last Updated: 2024-01-31

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-17

Study Completion Date

2025-04-30

Brief Summary

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Muscle wasting occurs rapidly in critically ill patients and impacts both short and long term outcomes. Altered protein metabolism drives muscle loss in ICU patients, with muscle protein breakdown exceeding muscle protein synthesis (MPS). Interventions aimed at attenuating muscle loss by stimulating MPS rates are hampered by a lack of knowledge on altered muscle protein turnover rates during critical illness. Only a few studies have specifically assessed muscle protein synthesis by using contemporary intravenous stable isotope infusions, which allows the assessment of MPS over a short (\<9 hours) period of time. Results from such acute studies can be difficult to extend or translate into long-term clinical practice and outcomes. Oral deuterated water (2H2O) dosing provides an alternative method that can be utilized to extend the measurement of muscle protein synthesis over a period of several days or weeks. It could therefore provide a valuable tool to study muscle protein synthesis during ICU admission and the impact of different anabolic interventions. Although multiple studies using the deuterated water methodology have been performed in both healthy volunteers and patients, it has not yet been performed in critically ill patients.

In this prospective study the investigators aim to assess fractional rates of muscle protein synthesis over a period of (maximal) 7 days in critically ill patients admitted to the intensive care unit. Secondly, the investigators aim to assess mechanisms of acute muscle wasting on an microscopic, ultrastructural and molecular level. Furthermore, the investigators aim to investigate to what extent muscle fibre size is recovered 3 months after ICU discharge.

Detailed Description

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Conditions

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Critical Illness Muscle Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age \>18y
* admitted to ICU
* enteral nutrition line in situ
* arterial line (any location) in situ
* expected stay ICU \>7d

Exclusion Criteria

* spinal cord injury
* chronic use of corticosteroids before hospital admission
* Contraindication to enteral infusion (e.g. due to GI-tract perforation)
* Kidney or liver failure
* therapeutic anti coagulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role collaborator

Frank Vandenabeele

OTHER

Sponsor Role lead

Responsible Party

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Frank Vandenabeele

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frank Vandenabeele, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Jessa Hospital

Hasselt, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Michelle Weijzen, Dr.

Role: CONTACT

Phone: 003211268706

Email: [email protected]

Frank Vandenabeele, Prof.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bjorn Stessel, PhD

Role: primary

Other Identifiers

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2022/165

Identifier Type: -

Identifier Source: org_study_id