Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
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|ClinicalTrials.gov Identifier: NCT02332629|
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : April 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthrosis||Drug: Methylprednisolone Drug: Isotonic Sodium Chloride||Phase 3|
The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects on postoperative pain, postoperative nausea and vomiting are well-documented.
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
Other Name: Solu-Medrol
Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride
Drug: Isotonic Sodium Chloride
- Change in plasma Syndecan-1 from baseline (before surgery) to 24 hours after surgery [ Time Frame: baseline to 24 hours ]
- Change in plasma soluble Thrombomodulin from baseline (before surgery) to 24 hours after surgery [ Time Frame: baseline to 24 hours ]
- Change in plasma SE-Selectin from baseline (before surgery) to 24 hours after surgery [ Time Frame: One day after surgery ]
- Change in plasma VE-Cadherin from baseline (before surgery) to 24 hours after surgery [ Time Frame: baseline to 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332629
|Copenhagen NV, Denmark, 2400|
|Principal Investigator:||Viktoria Lindberg-Larsen, MD||Section for Surgical Pathophysiology, Rigshospitalet|