Osteoarthrosis Clinical Trial
Official title:
Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty
Verified date | April 2016 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
This study evaluates the pathophysiological effects of a single dose methylprednisolone
administered prior to total knee-arthroplasty surgery (TKA). The investigators examine the
effect on the endothelial glycocalyx shedding due to surgical trauma.
Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will
receive placebo.
The investigators hypothesize that the group receiving methylprednisolone will experience
reduction in glycocalyx degradation compared to the placebo-group, early after TKA.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Osteoarthrosis - Undergoing total unilateral knee-arthroplasty surgery - Speak and understand Danish - Have given informed consent Exclusion Criteria: - Revision, bilateral og uni chamber knee-arthroplasty surgery - General anaesthesia - Allergy or intolerance towards Methylprednisolone - Local or systemic infection - Permanent systemic treatment with steroids within 30 days preoperatively - Insulin-dependent diabetes - Active treatment of ulcer within 3 months preoperatively - Cancer disease - Autoimmune disease incl. rheumatoid arthritis - Pregnant or breast feeding women - Menopause <1 year |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg Hospital | Copenhagen NV |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Bispebjerg Hospital |
Denmark,
Chappell D, Hofmann-Kiefer K, Jacob M, Rehm M, Briegel J, Welsch U, Conzen P, Becker BF. TNF-alpha induced shedding of the endothelial glycocalyx is prevented by hydrocortisone and antithrombin. Basic Res Cardiol. 2009 Jan;104(1):78-89. doi: 10.1007/s00395-008-0749-5. Epub 2008 Oct 3. — View Citation
Chappell D, Jacob M, Hofmann-Kiefer K, Bruegger D, Rehm M, Conzen P, Welsch U, Becker BF. Hydrocortisone preserves the vascular barrier by protecting the endothelial glycocalyx. Anesthesiology. 2007 Nov;107(5):776-84. — View Citation
Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593. Review. — View Citation
Johansson PI, Stensballe J, Rasmussen LS, Ostrowski SR. A high admission syndecan-1 level, a marker of endothelial glycocalyx degradation, is associated with inflammation, protein C depletion, fibrinolysis, and increased mortality in trauma patients. Ann Surg. 2011 Aug;254(2):194-200. doi: 10.1097/SLA.0b013e318226113d. — View Citation
Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. — View Citation
Khan SK, Malviya A, Muller SD, Carluke I, Partington PF, Emmerson KP, Reed MR. Reduced short-term complications and mortality following Enhanced Recovery primary hip and knee arthroplasty: results from 6,000 consecutive procedures. Acta Orthop. 2014 Feb;85(1):26-31. doi: 10.3109/17453674.2013.874925. Epub 2013 Dec 20. — View Citation
Malviya A, Martin K, Harper I, Muller SD, Emmerson KP, Partington PF, Reed MR. Enhanced recovery program for hip and knee replacement reduces death rate. Acta Orthop. 2011 Oct;82(5):577-81. doi: 10.3109/17453674.2011.618911. Epub 2011 Sep 6. — View Citation
Ostrowski SR, Johansson PI. Endothelial glycocalyx degradation induces endogenous heparinization in patients with severe injury and early traumatic coagulopathy. J Trauma Acute Care Surg. 2012 Jul;73(1):60-6. doi: 10.1097/TA.0b013e31825b5c10. — View Citation
Rehm M, Bruegger D, Christ F, Conzen P, Thiel M, Jacob M, Chappell D, Stoeckelhuber M, Welsch U, Reichart B, Peter K, Becker BF. Shedding of the endothelial glycocalyx in patients undergoing major vascular surgery with global and regional ischemia. Circulation. 2007 Oct 23;116(17):1896-906. Epub 2007 Oct 8. — View Citation
Woodcock TE, Woodcock TM. Revised Starling equation and the glycocalyx model of transvascular fluid exchange: an improved paradigm for prescribing intravenous fluid therapy. Br J Anaesth. 2012 Mar;108(3):384-94. doi: 10.1093/bja/aer515. Epub 2012 Jan 29. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma Syndecan-1 from baseline (before surgery) to 24 hours after surgery | baseline to 24 hours | No | |
Secondary | Change in plasma soluble Thrombomodulin from baseline (before surgery) to 24 hours after surgery | baseline to 24 hours | No | |
Secondary | Change in plasma SE-Selectin from baseline (before surgery) to 24 hours after surgery | One day after surgery | No | |
Secondary | Change in plasma VE-Cadherin from baseline (before surgery) to 24 hours after surgery | baseline to 24 hours | No |
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