Clinical trial NCT02133300: NMES in Critically Ill Patients
Official title: Neuromuscular Electrical Stimulation in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Patients With a Predicted Prolonged ICU Stay
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.


Eligibility criteria: Inclusion Criteria:

* All adult ICU patients with a predicted prolonged ICU stay

Exclusion Criteria:

* Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, ...)
* Receiving neuromuscular blocking agents
* Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease )
* Focal neurological conditions of the pelvis and/or lower limb
* Skin disease (e.g. burns)
* Presence of a pace-maker or defibrillator
* Hemodynamic or Respiratory Instability, active cardiac ischemia
* High fever (\>39°)
* Pregnancy
* Brain death
* Intracranial pressure \>20 mmHg
* An anticipated fatal outcome
* Psychiatric disorders or severe agitation
* Re-admission to the ICU

Primary outcomes:
measure: Muscle thickness
timeFrame: pre-intervention period
measure: Muscle thickness
timeFrame: post intervention period
Secondary outcomes:
measure: Muscle strength (MRC & HHD)
timeFrame: pre intervention period
measure: Muscle fiber thickness
timeFrame: post intervention period
measure: Muscle strength (MRC & HHD)
timeFrame: post intervention period
measure: Protein balance
timeFrame: post intervention
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
References:
citation: Segers J, Vanhorebeek I, Langer D, Charususin N, Wei W, Frickx B, Demeyere I, Clerckx B, Casaer M, Derese I, Derde S, Pauwels L, Van den Berghe G, Hermans G, Gosselink R. Early neuromuscular electrical stimulation reduces the loss of muscle mass in critically ill patients - A within subject randomized controlled trial. J Crit Care. 2021 Apr;62:65-71. doi: 10.1016/j.jcrc.2020.11.018. Epub 2020 Nov 28.