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Clinical Trials/NCT06234826
NCT06234826
Recruiting
Not Applicable

Skeletal Muscle Wasting in ICU Patients

Frank Vandenabeele1 site in 1 country20 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Frank Vandenabeele
Enrollment
20
Locations
1
Primary Endpoint
muscle protein synthesis rate (%/h)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
April 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Frank Vandenabeele
Responsible Party
Sponsor Investigator
Principal Investigator

Frank Vandenabeele

principal investigator

Hasselt University

Eligibility Criteria

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

Outcomes

Primary Outcomes

muscle protein synthesis rate (%/h)

Time Frame: 7 days of stay at the intensive care unit

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

Secondary Outcomes

  • patient characteristics (medical2)(7 days of stay at the intensive care unit)
  • patient characteristic- LOS(Stay at the intensive care unit and Hospital (up to 1 year))
  • Quality of life questionnaire(3 months post-hospital discharge)
  • skeletal muscle fiber characteristics 1(7 days of stay at the intensive care unit)
  • patient characteristic- age(7 days of stay at the intensive care unit)
  • patient characteristic- APACHE score II(7 days of stay at the intensive care unit)
  • habitual food(3 months post-hospital discharge)
  • Functional capacity 1(3 months post-hospital discharge)
  • patient characteristics (medical1)(7 days of stay at the intensive care unit)
  • patient characteristic- food intake(7 days of stay at the intensive care unit)
  • muscle volume(3 months post-hospital discharge)
  • habitual activity(3 months post-hospital discharge)
  • muscle hand grip strength(3 months post-hospital discharge)
  • patient characteristic- body weight(7 days of stay at the intensive care unit)
  • patient characteristics (medical3)(7 days of stay at the intensive care unit)
  • Functional capacity 2(3 months post-hospital discharge)
  • 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)
  • patient characteristic- height(7 days of stay at the intensive care unit)
  • patient characteristic- sex(7 days of stay at the intensive care unit)
  • leg muscle strength(3 months post-hospital discharge)
  • Quality of life questionnaires(3 months post-hospital discharge)

Study Sites (1)

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