Skeletal Muscle Wasting in ICU Patients

Critical Illness Clinical Trial

— IC-MPS  

Official title:

Skeletal Muscle Wasting in ICU Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234826
• Other study ID #: 2022/165
• Status: Recruiting
• Start date: April 17, 2023
• Est. completion date: April 2025

Study information

• Verified date: January 2024
• Source: Hasselt University
• Contact: Michelle Weijzen, Dr.
• Phone: 003211268706
• Email: michelle.weijzen[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Atrophy
• Muscular Atrophy

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Frank Vandenabeele	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	skeletal muscle fiber characteristics 1	cross sectional area of muscle fibers	7 days of stay at the intensive care unit
Secondary	skeletal muscle fiber characteristics 2	amount and distribution of muscle fibers (distribution will be calculated as: amount of type X / total amount of fibres)	7 days of stay at the intensive care unit
Secondary	mRNA expression in skeletal muscle tissue 1	mRNA expression in skeletal muscle tissue of MAFBx (atrophy marker)	7 days of stay at the intensive care unit
Secondary	mRNA expression in skeletal muscle tissue 2	mRNA expression in skeletal muscle tissue of MurF1 (atrophy marker)	7 days of stay at the intensive care unit
Secondary	mRNA expression in skeletal muscle tissue 3	mRNA expression in skeletal muscle tissue of FOXO (atrophy marker)	7 days of stay at the intensive care unit
Secondary	patient characteristic- age	age in years	7 days of stay at the intensive care unit
Secondary	patient characteristic- body weight	body weight in kg	7 days of stay at the intensive care unit
Secondary	patient characteristic- height	height in m	7 days of stay at the intensive care unit
Secondary	patient characteristic- sex	male or female	7 days of stay at the intensive care unit
Secondary	patient characteristics (medical1)	mechanical ventilation (duration in days)	7 days of stay at the intensive care unit
Secondary	patient characteristics (medical2)	comorbidities (list of comorbidities)	7 days of stay at the intensive care unit
Secondary	patient characteristics (medical3)	reason hospital admission	7 days of stay at the intensive care unit
Secondary	patient characteristic- APACHE score II	APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71.	7 days of stay at the intensive care unit
Secondary	patient characteristic- food intake	food intake (energy in kcal and protein intake in g/kg/d)	7 days of stay at the intensive care unit
Secondary	patient characteristic- LOS	Length of stay ICU and hospital (in days)	Stay at the intensive care unit and Hospital (up to 1 year)
Secondary	muscle volume	3d ultrasound assessed at follow up visit	3 months post-hospital discharge
Secondary	habitual food	Assessed using questionnaires at follow up visit (higher score means better intake)	3 months post-hospital discharge
Secondary	habitual activity	Assessed using questionnaires at follow up visit (higher score means better intake)	3 months post-hospital discharge
Secondary	muscle hand grip strength	hand grip strength using the JAMAR dynamometer in kg	3 months post-hospital discharge
Secondary	leg muscle strength	1RM upper leg at follow up visit	3 months post-hospital discharge
Secondary	Functional capacity 1	SPPB at follow up visit (short physical performance battery)	3 months post-hospital discharge
Secondary	Functional capacity 2	6min walking test at follow up visit	3 months post-hospital discharge
Secondary	Quality of life questionnaire	SF-36 at follow up visit (Short Form Health Survey 36 items) range score between 0-100, lower score represents great health related problems	3 months post-hospital discharge
Secondary	Quality of life questionnaires	Euro-QoL-5D-5-level at follow up visit (Euro quality of life 5 Dimension 5 level) Answers can be converted into EQ-5D index, an utility scores anchored at 0 for death and 1 for perfect health	3 months post-hospital discharge