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NMES in Critically Ill Patients (NESCI)

Primary Purpose

Critically Ill Patients With a Predicted Prolonged ICU Stay

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
electrical stimulation
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients With a Predicted Prolonged ICU Stay

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

electrical stimulation

control

Arm Description

Compex 3 professional NMES for 60' per day

Outcomes

Primary Outcome Measures

Muscle thickness
Ultrasound measure in cm
Muscle thickness
Ultrasound measure in cm

Secondary Outcome Measures

Muscle strength (MRC & HHD)
MRC: scale HHD: MicroFet, in kg Force
Muscle fiber thickness
biopsy using Bergström-Stille 5mm needles
Muscle strength (MRC & HHD)
MRC: scale HHD: MicroFET, in kg Force
Protein balance
biopsy using Bergström-Stille 5mm needles

Full Information

First Posted
May 6, 2014
Last Updated
February 20, 2018
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02133300
Brief Title
NMES in Critically Ill Patients
Acronym
NESCI
Official Title
Neuromuscular Electrical Stimulation in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients With a Predicted Prolonged ICU Stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrical stimulation
Arm Type
Experimental
Arm Description
Compex 3 professional NMES for 60' per day
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
electrical stimulation
Primary Outcome Measure Information:
Title
Muscle thickness
Description
Ultrasound measure in cm
Time Frame
pre-intervention period
Title
Muscle thickness
Description
Ultrasound measure in cm
Time Frame
post intervention period
Secondary Outcome Measure Information:
Title
Muscle strength (MRC & HHD)
Description
MRC: scale HHD: MicroFet, in kg Force
Time Frame
pre intervention period
Title
Muscle fiber thickness
Description
biopsy using Bergström-Stille 5mm needles
Time Frame
post intervention period
Title
Muscle strength (MRC & HHD)
Description
MRC: scale HHD: MicroFET, in kg Force
Time Frame
post intervention period
Title
Protein balance
Description
biopsy using Bergström-Stille 5mm needles
Time Frame
post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3001
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
33285371
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.
Results Reference
derived

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NMES in Critically Ill Patients

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