NCT02133300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

3.4 years

First QC Date

May 6, 2014

Last Update Submit

February 20, 2018

Conditions

Critically Ill Patients With a Predicted Prolonged ICU Stay

Outcome Measures

Primary Outcomes (2)

  • Muscle thickness

    Ultrasound measure in cm

    pre-intervention period

  • Muscle thickness

    Ultrasound measure in cm

    post intervention period

Secondary Outcomes (4)

  • Muscle strength (MRC & HHD)

    pre intervention period

  • Muscle fiber thickness

    post intervention period

  • Muscle strength (MRC & HHD)

    post intervention period

  • Protein balance

    post intervention

Study Arms (2)

electrical stimulation

EXPERIMENTAL

Compex 3 professional NMES for 60' per day

Other: electrical stimulation

control

NO INTERVENTION

Interventions

electrical stimulationOTHER
electrical stimulation

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult ICU patients with a predicted prolonged ICU stay

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3001, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 33285371DERIVED

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc.

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

BE(1)