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Critical Illness Polyneuromyopathy - The effect of electrical nerve stimulation.


- candidate number4712
- NTR NumberNTR1578
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-dec-2008
- Secondary IDsP08-50 METC Medisch Spectrum Twente
- Public TitleCritical Illness Polyneuromyopathy - The effect of electrical nerve stimulation.
- Scientific TitleCritical Illness Polyneuromyopathy - The effect of electrical nerve stimulation.
- ACRONYMCIPM08
- hypothesisMuscle weakness in patients admitted to the Intensive Care Unit lengthens duration of mechanical ventilation, weaning and hospital stay. One of the causes for muscle weakness is critical illness polyneuromyopathy (CIPM). The incidence of CIPM varies between 25 and 100%, depending on patient population, diagnostic criteria and timing of measurements. Despite many previous studies, the pathophysiology and risk factors of CIPM remain unclear. More importantly, there is yet no therapy for this disease. Electrical stimulation has shown to improve muscle strength, cross-sectional area of muscle and prevent muscle atrophy. We hypothesize that electrical stimulation of nerves in patients with CIPM will improve muscle strength.
- Healt Condition(s) or Problem(s) studiedCritical Illness polyneuromyopathy
- Inclusion criteria1. Age above 18 years;
2. aortic surgery;
3. mitral valve repair or replacement surgery;
4. double valve surgery;
5. coronary artery surgery with poor left ventricle function;
6. patients scheduled for cardiovascular surgery with chronic kidney failure or kidney-function disorders;
7. COPD patients scheduled for cardiovascular surgery with FEV1 < 1.5 Liter;
8. patients with preexisting pulmonary disorders scheduled for cardiovascular surgery;
9. admission at thoracic ICU;
10. obtained informed consent.
- Exclusion criteria1. Existing neuropathy or myopathy;
2. not having 4 limbs.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-feb-2009
- planned closingdate30-jun-2009
- Target number of participants10
- InterventionsElectrical nerve stimulation of the N. peroneus communis on one leg. Randomization determines whether the dominant or non-dominant leg is stimulated. Stimulation will be applied daily for 30 minutes on 9 weekdays.
- Primary outcomeDifference in muscle force (percentage) between stimulated and non-stimulated legs on day 1 and day 10.
- Secondary outcomeValues of electrophysiological features, such as:
1. CMAP;
2. SNAP;
3. conduction velocity;
4. MUAPs;
5. spontaneous EMG acitivity;
6. direct muscle stimulation (DMS).
- TimepointsPatients will receive muscle force measurements of the M. extensor hallucis longus on day 0. On day 1-10 muscle force and electrophysiological measurements will take place daily. On day 1-9 electrical stimulation of the N. peroneus communis will be applied.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J Vermeijden
- CONTACT for SCIENTIFIC QUERIES J Vermeijden
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede
- Publications
- Brief summaryMuscle weakness in patients admitted to the Intensive Care Unit (ICU) lengthens duration of mechanical ventilation, weaning and hospital stay. One of the causes for muscle weakness is critical illness polyneuromyopathy (CIPM). The incidence of CIPM varies between 25 and 100%, depending on patient population, diagnostic criteria and timing of measurements. Despite many previous studies, the pathophysiology and risk factors of CIPM remain unclear. More importantly, there is yet no therapy for this disease. Electrical stimulation has shown to improve muscle strength, cross-sectional area of muscle and prevent muscle atrophy. We hypothesize that electrical stimulation of nerves in patients with CIPM will improve muscle strength. Patients who are expected to be admitted to the thoracic ICU for longer than 2 days will be included in this study. Some of these patients will develop CIPM. Patients will receive muscle force measurements of the M. extensor hallucis longus on day 0. On day 1-10 muscle force and electrophysiological measurements will take place daily. On day 1-9 electrical stimulation of the N. peroneus communis on one leg will be applied for 30 minutes. Randomization determines which leg will be stimulated (dominant or non-dominant). The primary outcome measure is the difference in muscle force (percentage) between stimulated and non-stimulated legs on day 1 and day 10. Also, electrophysiological measurements will be evaluated.
- Main changes (audit trail)
- RECORD10-dec-2008 - 19-mrt-2009


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