Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
NCT ID: NCT02332629
Last Updated: 2016-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2015-01-31
2016-04-30
Brief Summary
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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.
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Detailed Description
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Postoperatively, activation and / or dysregulation of the inflammatory system influence on the endothelial glycocalyx. Damage of the vascular endothelia increases the risk of cardiovascular and thromboembolic complications.
In animal studies glucocorticoids have been found to preserve the endothelial glycocalyx and the vascular barrier.
The effect of glucocorticoids on human endothelial glycocalyx after surgery is unknown and calls for further investigation.
This study is embedded in a primary study registrated as: NCT02319343
For further details please view the EudraCT registration:
EudraCT nr.: 2014-003395-23
Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo
Interventions
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Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Isotonic Sodium Chloride
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing total unilateral knee-arthroplasty surgery
* Speak and understand Danish
* Have given informed consent
Exclusion Criteria
* 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
55 Years
80 Years
ALL
No
Sponsors
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Bispebjerg Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Viktoria Oline Lindberg-Larsen
MD, research assistant
Principal Investigators
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Viktoria Lindberg-Larsen, MD
Role: PRINCIPAL_INVESTIGATOR
Section for Surgical Pathophysiology, Rigshospitalet
Locations
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Bispebjerg Hospital
Copenhagen NV, , Denmark
Countries
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References
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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.
Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.
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.
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.
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.
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.
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. doi: 10.1161/CIRCULATIONAHA.106.684852. Epub 2007 Oct 8.
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.
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. doi: 10.1097/01.anes.0000286984.39328.96.
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.
Other Identifiers
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HK_VL_08_2014a
Identifier Type: -
Identifier Source: org_study_id
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