Critical IllnessIC-MPSNCT06234826
Skeletal Muscle Wasting in ICU Patients
An observational study of Critical Illness and Muscle Atrophy, run by Frank Vandenabeele at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness, Muscle Atrophy
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2023to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In total 20 patients admitted to the ICU will be included.
Who may be able to join
- age >18y
- admitted to ICU
- enteral nutrition line in situ
- arterial line (any location) in situ
- expected stay ICU >7d
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Frank Vandenabeele, Prof. contact
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Bjorn Stessel, PhD, bjorn.stessel@jessazh.be
About this study
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
- Medical subject headings
- Critical Illness, Muscular Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle protein synthesis rate (%/h)
obtained by using deuterated water, muscle biopsy sampling and blood sampling
Measured: 7 days of stay at the intensive care unit
Secondary outcomes (24)
skeletal muscle fiber characteristics 1
cross sectional area of muscle fibers
Measured: 7 days of stay at the intensive care unit
skeletal muscle fiber characteristics 2
amount and distribution of muscle fibers (distribution will be calculated as: amount of type X / total amount of fibres)
Measured: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 1
mRNA expression in skeletal muscle tissue of MAFBx (atrophy marker)
Measured: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 2
mRNA expression in skeletal muscle tissue of MurF1 (atrophy marker)
Measured: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 3
mRNA expression in skeletal muscle tissue of FOXO (atrophy marker)
Measured: 7 days of stay at the intensive care unit
patient characteristic- age
age in years
Measured: 7 days of stay at the intensive care unit
patient characteristic- body weight
body weight in kg
Measured: 7 days of stay at the intensive care unit
patient characteristic- height
height in m
Measured: 7 days of stay at the intensive care unit
patient characteristic- sex
male or female
Measured: 7 days of stay at the intensive care unit
patient characteristics (medical1)
mechanical ventilation (duration in days)
Measured: 7 days of stay at the intensive care unit
patient characteristics (medical2)
comorbidities (list of comorbidities)
Measured: 7 days of stay at the intensive care unit
patient characteristics (medical3)
reason hospital admission
Measured: 7 days of stay at the intensive care unit
patient characteristic- APACHE score II
APACHE II score = acute physiology score + age points + chronic health points. Minimum score = 0; maximum score = 71.
Measured: 7 days of stay at the intensive care unit
patient characteristic- food intake
food intake (energy in kcal and protein intake in g/kg/d)
Measured: 7 days of stay at the intensive care unit
patient characteristic- LOS
Length of stay ICU and hospital (in days)
Measured: Stay at the intensive care unit and Hospital (up to 1 year)
muscle volume
3d ultrasound assessed at follow up visit
Measured: 3 months post-hospital discharge
habitual food
Assessed using questionnaires at follow up visit (higher score means better intake)
Measured: 3 months post-hospital discharge
habitual activity
Assessed using questionnaires at follow up visit (higher score means better intake)
Measured: 3 months post-hospital discharge
muscle hand grip strength
hand grip strength using the JAMAR dynamometer in kg
Measured: 3 months post-hospital discharge
leg muscle strength
1RM upper leg at follow up visit
Measured: 3 months post-hospital discharge
Functional capacity 1
SPPB at follow up visit (short physical performance battery)
Measured: 3 months post-hospital discharge
Functional capacity 2
6min walking test at follow up visit
Measured: 3 months post-hospital discharge
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
Measured: 3 months post-hospital discharge
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
Measured: 3 months post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start17 Apr 2023
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Vandenabeele
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor-investigator, Frank Vandenabeele, Hasselt University
- Investigators
- Frank Vandenabeele, Prof., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234826
- Sponsor's protocol ID
- 2022/165
- Acronym
- IC-MPS
- Status last verified
- Jan 2024
- First submitted
- 16 May 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Wasting in ICU Patients
- ClinicalTrials.gov ID
- NCT06234826
- Acronym / sponsor ID
- IC-MPS / 2022/165
- Conditions
- Critical Illness, Muscle Atrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Frank VandenabeeleUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In total 20 patients admitted to the ICU will be included.
Key inclusion criteria (5 listed)
- age >18y
- admitted to ICU
- enteral nutrition line in situ
- arterial line (any location) in situ
- expected stay ICU >7d
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
24 secondary outcomes
skeletal muscle fiber characteristics 1
Time frame: 7 days of stay at the intensive care unit
skeletal muscle fiber characteristics 2
Time frame: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 1
Time frame: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 2
Time frame: 7 days of stay at the intensive care unit
mRNA expression in skeletal muscle tissue 3
Time frame: 7 days of stay at the intensive care unit
patient characteristic- age
Time frame: 7 days of stay at the intensive care unit
patient characteristic- body weight
Time frame: 7 days of stay at the intensive care unit
patient characteristic- height
Time frame: 7 days of stay at the intensive care unit
patient characteristic- sex
Time frame: 7 days of stay at the intensive care unit
patient characteristics (medical1)
Time frame: 7 days of stay at the intensive care unit
patient characteristics (medical2)
Time frame: 7 days of stay at the intensive care unit
patient characteristics (medical3)
Time frame: 7 days of stay at the intensive care unit
patient characteristic- APACHE score II
Time frame: 7 days of stay at the intensive care unit
patient characteristic- food intake
Time frame: 7 days of stay at the intensive care unit
patient characteristic- LOS
Time frame: Stay at the intensive care unit and Hospital (up to 1 year)
muscle volume
Time frame: 3 months post-hospital discharge
habitual food
Time frame: 3 months post-hospital discharge
habitual activity
Time frame: 3 months post-hospital discharge
muscle hand grip strength
Time frame: 3 months post-hospital discharge
leg muscle strength
Time frame: 3 months post-hospital discharge
Functional capacity 1
Time frame: 3 months post-hospital discharge
Functional capacity 2
Time frame: 3 months post-hospital discharge
Quality of life questionnaire
Time frame: 3 months post-hospital discharge
Quality of life questionnaires
Time frame: 3 months post-hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Vandenabeele, Prof. contact
Frank Vandenabeele, Prof. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Muscle Atrophy, run by Frank Vandenabeele at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Weijzen, Dr. (003211268706, michelle.weijzen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle protein synthesis rate (%/h) (time frame: 7 days of stay at the intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.