NCT02332629

Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty

Effect of Preoperative Intravenous High Dose Methylprednisolone on Endothelial Function in Patients Scheduled for Total Knee-arthroplasty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Osteoarthrosis

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
DRUG	Isotonic Sodium Chloride	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-01-07
• Last updated: 2016-04-08

Locations

1 site across 1 country: Denmark