Critically Ill Patients With a Predicted Prolonged ICU StayNESCINCT02133300

NMES in Critically Ill Patients

A study testing electrical stimulation in people with Critically Ill Patients With a Predicted Prolonged ICU Stay, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 110 years
Conditions the study is for: Critically Ill Patients With a Predicted Prolonged ICU Stay
What is being tested?: electrical stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteBelgium
Study dates: May 2014to Oct 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 110 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All adult ICU patients with a predicted prolonged ICU stay

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospitals Leuven
Leuven, Vlaams-Brabant, 3001

Other trials in Belgium

About this study

Official title: Neuromuscular Electrical Stimulation in Critically Ill Patients

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
Being tested: electrical stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

electrical stimulationOther

Study groups in NCT02133300
Study group	Role	What they receive
electrical stimulation	Experimental	Compex 3 professional NMES for 60' per day Receives: Other: electrical stimulation
control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle thickness
Ultrasound measure in cm
Measured: pre-intervention period
Muscle thickness
Ultrasound measure in cm
Measured: post intervention period

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Oct 2017

First posted8 May 2014 (estimated)
Study startMay 2014
Primary completionOct 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Critically Ill Patients With a Predicted Prolonged ICU StayStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02133300
Sponsor's protocol ID: u0064027
Acronym: NESCI
Status last verified: Feb 2018
First submitted: 6 May 2014
Last updated: 22 Feb 2018
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 33285371

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromuscular Electrical Stimulation in Critically Ill Patients
ClinicalTrials.gov ID: NCT02133300
Acronym / sponsor ID: NESCI / u0064027
Conditions: Critically Ill Patients With a Predicted Prolonged ICU Stay
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: KU LeuvenUniversity, hospital or other
Study start: May 2014
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 8 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
electrical stimulation	Experimental	Other: electrical stimulationCompex 3 professional NMES for 60' per day
control	No intervention	–

Who may qualify

Ages: 18 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All adult ICU patients with a predicted prolonged ICU stay

Key exclusion criteria (14 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
electrical stimulation	Other	electrical stimulation

Primary outcome

Muscle thickness
Time frame: pre-intervention period
Ultrasound measure in cm
Muscle thickness
Time frame: post intervention period
Ultrasound measure in cm

4 secondary outcomes

Muscle strength (MRC & HHD)
Time frame: pre intervention period
Muscle fiber thickness
Time frame: post intervention period
Muscle strength (MRC & HHD)
Time frame: post intervention period
Protein balance
Time frame: post intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
Derived from this study: PubMed 33285371Segers 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing electrical stimulation in people with Critically Ill Patients With a Predicted Prolonged ICU Stay, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle thickness (time frame: pre-intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.