Skeletal Muscle Wasting in ICU Patients

NCT06234826 | Unknown

• 1 other identifier: 2022/165
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Muscle Atrophy

Outcome Measures

Primary Outcomes (1)

• muscle protein synthesis rate (%/h)

  obtained by using deuterated water, muscle biopsy sampling and blood sampling

  7 days of stay at the intensive care unit

Secondary Outcomes (24)

• skeletal muscle fiber characteristics 1

  7 days of stay at the intensive care unit

• skeletal muscle fiber characteristics 2

  7 days of stay at the intensive care unit

• mRNA expression in skeletal muscle tissue 1

  7 days of stay at the intensive care unit

• mRNA expression in skeletal muscle tissue 2

  7 days of stay at the intensive care unit

• mRNA expression in skeletal muscle tissue 3

  7 days of stay at the intensive care unit

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In total 20 patients admitted to the ICU will be included.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Vandenabeele: lead
• Jessa Hospital: collaborator

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Frank Vandenabeele, Prof.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Weijzen, Dr.

CONTACT

003211268706; michelle.weijzen@uhasselt.be

Frank Vandenabeele, Prof.

CONTACT

frank.vandenabeele@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: January 31, 2024
• Study Start: April 17, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

BE (1)