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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1578 |
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Date of registration:
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10/12/2008 |
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Primary sponsor: |
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Public title:
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Critical Illness Polyneuromyopathy - The effect of electrical nerve stimulation.
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Scientific title:
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Critical Illness Polyneuromyopathy - The effect of electrical nerve stimulation. - CIPM08 |
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Date of first enrolment:
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1/2/2009 |
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Target sample size:
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10 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1578 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: 2 or more arms, non-randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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J
Vermeijden |
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Address:
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Haaksbergerstraat 55
7513 ER
Enschede
The Netherlands |
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Telephone:
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+31 (0)534872000 |
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Email:
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j.vermeijden@ziekenhuis-mst.nl |
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Affiliation:
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Name:
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J
Vermeijden |
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Address:
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Haaksbergerstraat 55
7513 ER
Enschede
The Netherlands |
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Telephone:
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+31 (0)534872000 |
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Email:
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j.vermeijden@ziekenhuis-mst.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. Existing neuropathy or myopathy;
2. not having 4 limbs.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Critical Illness polyneuromyopathy
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Intervention(s)
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Electrical 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.
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Primary Outcome(s)
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Difference in muscle force (percentage) between stimulated and non-stimulated legs on day 1 and day 10.
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Secondary Outcome(s)
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Values of electrophysiological features, such as:
1. CMAP;
2. SNAP;
3. conduction velocity;
4. MUAPs;
5. spontaneous EMG acitivity;
6. direct muscle stimulation (DMS).
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Source(s) of Monetary Support
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Medisch Spectrum Twente, Enschede
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