To investigate the feasibility of Bergström needle biopsies of the vastus lateralis muscle, and NIRS measurements of the gastrocnemius muscle in post-ICU patients.
ID
Source
Brief title
Condition
- Other condition
- Vitamin related disorders
Synonym
Health condition
Post-Intensive Care Syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is the feasibility of 3 mm Bergstro*m biopsies of
the vastus lateralis muscle and NIRS measurements of the gastrocnemius muscle
in post-ICU patients. In order to determine this the following main parameters
will be collected: - The acceptability for participation in the study, which is
expressed as the number of eligible patients approached for participation in
the study and the proportion of included patients as collected in a
pre-screenings log. - Results from the questionnaire following NIRS
measurements and the muscle biopsy, including pain rate, burden and willingness
to undergo a secondary NIRS and/or muscle biopsy at hospital discharge. - The
practical feasibility of NIRS measurement and biopsies of skeletal muscles in
the post-ICU patient. - Reliability of NIRS assessment of mitochondrial
capacity of the GA muscle in post-ICU patients as shown by reliable
post-exercise mVO2 recovery curves (R2 > 0.90 by mono-exponential curve
fitting).
Secondary outcome
The secondary endpoints include:
- Amount of muscle tissue retrieved from a single 3 mm Bergström vastus
lateralis muscle biopsy.
- Muscle fibre type distribution and size of the vastus lateralis muscle sample
of post ICU patients.
- (Serious) adverse effects (SAE) following muscle biopsy and NIRS of skeletal
muscles.
- Quality of the muscle biopsy, as determined by a successful whole genome
transcriptome analyses (RNA sequencing)
- Re-oxygenation rate measured using NIRS after the release of the occlusion
- Variation in NIRS-derived parameters between included subjects
Background summary
Muscle weakness following critical illness is mainly the result of decreased
skeletal muscle mitochondrial function and capacity. Decreased physical
condition after admission to the intensive care unit (ICU) is considered part
of the post-intensive care syndrome (PICS). It is associated with morbidity and
mortality in post-ICU patients. Specific nutritional components have the
potential to recover muscle mitochondrial function and, thereby, the physical
function of these patients, but it requires a randomized controlled trial to
investigate this. The gold standard of evaluating skeletal muscle mitochondrial
function is obtained by the respiratory function of muscle cells retrieved by
muscle biopsy, preferably by the modified Bergström biopsy technique. However,
patients recovering from ICU admission may be reluctant to undergo this
invasive method as they are still rehabilitating from critical illness. An
alternative method of evaluating mitochondrial functioning is muscle
near-infrared spectrometry (NIRS). NIRS measures the recovery of muscle oxygen
consumption (mVO2) post-exercise as a parameter for mitochondrial capacity.
Before conducting a randomized controlled trial to investigate the effect of
nutritional components on skeletal muscle mitochondrial functioning, we will
perform a prospective pilot study to evaluate the feasibility and acceptability
of muscle biopsy and NIRS in patients who will be discharged from the ICU.
Study objective
To investigate the feasibility of Bergström needle biopsies of the vastus
lateralis muscle, and NIRS measurements of the gastrocnemius muscle in post-ICU
patients.
Study design
Cross-sectional, single-centre pilot study.
Study burden and risks
After inclusion, NIRS with transient arterial occlusions of the gastrocnemius
muscle will be performed once. Subjects may experience some discomfort from the
transient occlusions. However, there is no risk of complications. Consequently,
a biopsy of the vastus lateralis will be performed once using a 3 mm modified
Bergström needle. An experienced physician will take muscle biopsies under
local anaesthesia but the procedure carries a small local hematoma risk and may
cause minor discomfort up to 24 h after the procedure. One questionnaire will
be taken directly after the NIRS and biopsy, but no follow-up is needed. A team
of experienced specialists will carry out the procedures to minimize the risk
of complications. There is no direct benefit for the participants except for
their contribution to scientific knowledge. This pilot study will provide
crucial information to set up a randomized controlled trial, which will provide
new insights into the effects of micronutrients on restoring skeletal muscle
mitochondrial function of post-ICU patients, for which evidence-based therapies
are currently lacking.
Willy Brandtlaan 10
Ede 6716 RP
NL
Willy Brandtlaan 10
Ede 6716 RP
NL
Listed location countries
Age
Inclusion criteria
1) >=18 years of age 2) Medical research council (MRC) sum score of at least 24
and less than 48 3) Serum haemoglobin of at least 5.0 mmol/L 4) BMI < 30 kg/m2
5) Admitted to an intensive care unit for at least 72 hours 6) exptected to be
discharged from the ICU within 48 hours 7) Written informed consent
Exclusion criteria
1) Known mitochondrial disease
2) Pre-existent muscle disease
3) Diabetes Mellitus
4) Life expectancy less than 6 months
5) Visibly high melanin content in the skin
6) Subcutaneous fat layer > 3cm covering the GA muscle (measured by
ultrasound)
7) Coagulopathy (i.e. platelet count; < 50 x10 9 cells/ml, INR > 2.0 or recent
treatment with therapeutic dosage of low molecular weight heparin)
8) Recent lower extremity surgery
9) Delirium (defined as a delirium observation screening scale (DOS) of at
least three)
10) Deemed incompetent to provide well-considered informed consent by the
treating physician
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84638.081.23 |