NMES in Critically Ill Patients

NCT ID: NCT02133300

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-10-31

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.

Conditions

Critically Ill Patients With a Predicted Prolonged ICU Stay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

electrical stimulation

Compex 3 professional NMES for 60' per day

Group Type: EXPERIMENTAL

electrical stimulation

Intervention Type: OTHER

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

electrical stimulation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Johan Segers

M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33285371 (View on PubMed)

Other Identifiers

u0064027

Identifier Type: -

Identifier Source: org_study_id