To examine the effect of a single session of whole-body NMES, with or without subsequent protein intake, on whole-body protein turnover
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Protein and amino acid metabolism disorders NEC
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Whole-body protein net balance (WPNB)
Secondary outcome
Whole body protein synthesis, breakdown, and oxidation. Forearm muscle glucose
uptake (i.e. a direct measure of muscle insulin sensitivity).
Background summary
Intensive care unit (ICU) stay is accompanied by muscle wasting (i.e. the loss
of muscle proteins) and ICU-acquired weakness (ICU-AW), which lead to increased
time of mechanical ventilation, morbidity, negative post-ICU consequences and
an overall decreased quality of life (QoL). The building blocks of our muscles,
called amino acids, are primarily acquired through dietary intake. A
fundamental cause for ICU-induced muscle wasting is an impaired response to the
anabolic properties of dietary protein. Neuromuscular electrical stimulation
(NMES) could stimulate muscle amino acid metabolism and alleviate some of these
negative consequences by reintroducing (involuntary) muscle contractions via
small electric currents. Previous research has shown that NMES of the
quadriceps muscle alleviated muscle wasting in sedated patients. At present,
the effects of a whole-body NMES approach in combination with timed protein
intake on amino acid metabolism in ICU patients remain unknown.
Study objective
To examine the effect of a single session of whole-body NMES, with or without
subsequent protein intake, on whole-body protein turnover
Study design
Randomised, placebo-controlled design with three parallel groups
Intervention
A single test day during which participants will either receive sham-NMES
followed by standard enteral nutrition (CON), whole-body NMES stimulation
followed by standard enteral nutrition (WB-NMES), or whole-body NMES followed
by a bolus of 20g protein (WB-NMES+PRO). Continuous intravenous infusion of
labelled amino acids will be combined with repeated blood samples. Doppler
ultrasound measurements will be performed before blood sampling to determine
forearm amino acid and glucose balances.
Study burden and risks
We will use the arterial and central venous lines that have already been
inserted for blood drawing. A cannula will be placed in the elbow crease to
collect blood. If not in situ, another cannula will be placed for stable
isotope infusion. Insertion of the catheters in a vein is comparable to a
routine blood draw, and the only risk is a small local hematoma. The standard
nutrition provided is part of the routine care in the ICU, so it poses no extra
risks. Short fasting periods are common in this population and pose no risks.
NMES has been applied to critically ill patients by ourselves and others, and
it has been proven safe when applied by trained staff. The protein bolus is
commonly used in current practice in ZGV. The labelled, non-radioactive amino
acid tracers that will be infused intravenously are produced under sterile
conditions according to GMP standards and routinely used in human skeletal
muscle metabolism research.
De Elst 1
Wageningen 6708 WD
NL
De Elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
• Aged >=18 years
• Expected to need mechanical ventilation for at least 48 hours, judged by
physician
• Expected to reach a Richmond Agitation-Sedation Scale (RASS) score of -4 or
-5 (complete
sedation), judged by physician
• Informed consent obtained from the next-of-kin
• Able to or are receiving enteral nutrition
• Have an arterial and a venous line
Exclusion criteria
• Spinal cord injury
• Previous surgery/local wounds that prohibit NMES
• Conditions that prohibit NMES (such as open wounds)
• Chronic neuromuscular disorders
• Acute Kidney Injury (AKI) II and III
• Undergoing continuous veno-venous hemofiltration (CVVH)
• Rhabdomyolysis (based on plasma creatine kinase levels)
• Neuromuscular blocking agents
• In the caloric restriction period of refeeding syndrome
• In prone position
• Burn wounds
• ICD/pacemaker
• Pregnant
• Deemed not suitable to participate based upon the judgement of the treating
intensivist
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL87298.028.24 |