Clinical trial NCT06234826: Skeletal Muscle Wasting in ICU Patients
Official title: Skeletal Muscle Wasting in ICU Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Muscle Atrophy
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2024-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In total 20 patients admitted to the ICU will be included.

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.


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

Primary outcomes:
measure: muscle protein synthesis rate (%/h)
timeFrame: 7 days of stay at the intensive care unit
Secondary outcomes:
measure: skeletal muscle fiber characteristics 1
timeFrame: 7 days of stay at the intensive care unit
measure: skeletal muscle fiber characteristics 2
timeFrame: 7 days of stay at the intensive care unit
measure: mRNA expression in skeletal muscle tissue 1
timeFrame: 7 days of stay at the intensive care unit
measure: mRNA expression in skeletal muscle tissue 2
timeFrame: 7 days of stay at the intensive care unit
measure: mRNA expression in skeletal muscle tissue 3
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- age
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- body weight
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- height
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- sex
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristics (medical1)
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristics (medical2)
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristics (medical3)
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- APACHE score II
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- food intake
timeFrame: 7 days of stay at the intensive care unit
measure: patient characteristic- LOS
timeFrame: Stay at the intensive care unit and Hospital (up to 1 year)
measure: muscle volume
timeFrame: 3 months post-hospital discharge
measure: habitual food
timeFrame: 3 months post-hospital discharge
measure: habitual activity
timeFrame: 3 months post-hospital discharge
measure: muscle hand grip strength
timeFrame: 3 months post-hospital discharge
measure: leg muscle strength
timeFrame: 3 months post-hospital discharge
measure: Functional capacity 1
timeFrame: 3 months post-hospital discharge
measure: Functional capacity 2
timeFrame: 3 months post-hospital discharge
measure: Quality of life questionnaire
timeFrame: 3 months post-hospital discharge
measure: Quality of life questionnaires
timeFrame: 3 months post-hospital discharge
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Hasselt University
name: Frank Vandenabeele, Prof.
role: PRINCIPAL_INVESTIGATOR
References: