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ISRCTN
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ISRCTN51508868
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ClinicalTrials.gov identifier
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Public title
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The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly elective surgery patients
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Scientific title
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The effect of peri-operative anti-inflammatory treatment on postoperative muscle weakness and muscle fatigue in elderly elective surgery patients: a double blinded randomized placebo-controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Could Pharmacological interventions designed to prevent inflammation-induced structural changes in the skeletal muscle reduce postoperative muscle weakness and muscle fatigue in elderly elective abdominal surgery patients?
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Lay summary
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Lay summary under review
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Ethics approval
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Brussels University Hospital Medical Ethical Committee (Universitair Ziekenhuis Brussel)
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Study design
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Double blinded randomised placebo-controlled trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Post-operative muscle weakness, fatigue and inflammation
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Participants - inclusion criteria
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All elderly (male or female, aged > 60 years) elective abdominal surgery patients
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Participants - exclusion criteria
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1. Unavailable one day before the surgical intervention
2. Presenting important inflammation preoperatively C-reactive protein (CRP)>10mg/L
3. Unable to understand or execute the test instructions due to cognitive impairment mini mental state examination (MMSE<23 / 30) and/or physical disability
4. Already using selective tumor necrosis factor (TNF)-alpha inhibitors, nitric oxide donors, fibrates, non-steroidal anti-inflammatory drugs (NSAID’s) or corticosteroids or when contra-indications for the use of one of these products exist
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Anticipated start date
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01/10/2011
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Anticipated end date
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01/10/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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N=100 (N=25 per treatment arm)
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Interventions
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Three different pharmacological interventions, each counter-acting different steps of the inflammation-induced proteolytic pathway in skeletal muscle, will be compared to placebo control:
1. Tumor necrosis factor-alpha (TNF-a) inhibitor [50mg Etanercept by subcutaneous (SC) injection 1 day preoperative, N=25)
2. Calpain inhibitor (16mg Molsidomine daily by mouth (per os), starting 1 day preoperative until 1 week postoperative, N=25)
3. Nuclear factor kappa-light-chain-enhancer of activated B cells (NF-eB) downregulator (267mg Fenofibrate daily, starting 1 day preoperative until 1 week postoperative N=25)
4. Placebo control (N=25)
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Primary outcome measure(s)
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1. Muscle performance: Maximal handgrip strength, muscle fatigue resistance and grip work will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
2. Self-perceived fatigue and pain: self-perceived fatigue (Fatigue subscale of the Profile of Mood State) and pain (Visual Analogue Scale) will be assessed one day before surgery, and 2, 4, 8 and 30 days post-surgery
3. Inflammation: circulating levels of pro- and anti-inflammatory cytokines and their intra-cellular gene expression in Peripheral Mononuclear Blood Cells. Overnight fasting serum samples will be collected from the non-dominant arm at one day before surgery, and 2, 4, 8 and 30 days post-surgery.
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Secondary outcome measure(s)
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Occurrence of adverse reactions and postoperative complications:
All participants will be questioned and monitored for adverse reactions (potentially related to the study medication, i.e. allergies, headache, hypotension) at day 2, 4, 8 and 30 post-surgery.
Occurrence of postoperative complications will be extracted from the patient’s medical record.
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Sources of funding
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1. University of Brussels (Belgium)
2. Brussels University Hospital (Belgium)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/pubmed/19808837
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Contact name
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Prof
Ivan
Bautmans
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Address
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Laarbeeklaan 103
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City/town
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Brussels
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Zip/Postcode
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1090
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Country
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Belgium
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Email
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ivan.bautmans@vub.ac.be
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Sponsor
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Vrije University Brussels [Vrije Universiteit Brussel] (Belgium)
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Address
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Frailty in Ageing Research Department
Laarbeeklaan 103
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City/town
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Brussels
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Zip/Postcode
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1090
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Country
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Belgium
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Email
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ivan.bautmans@vub.ac.be
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Sponsor website:
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http://www.vub.ac.be/FRIA
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Date applied
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20/09/2011
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Last edited
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09/11/2011
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Date ISRCTN assigned
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09/11/2011
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