临床试验/NCT05338021

NCT05338021已完成不适用

Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Knee Arthroplasty

The Affiliated Hospital of Qingdao University1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2022年5月25日最近更新: 2023年1月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: The Affiliated Hospital of Qingdao University
入组人数: 100
试验地点: 1
主要终点: Intra-articular vancomycin concentration

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 50 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age between 50 and 80
•Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

排除标准

•Diminished mental capacity
•Vancomycin allergy
•Chronic kidney disease stage III and stage IV

结局指标

主要结局

Intra-articular vancomycin concentration

时间窗: 2 hours, 8 hours and 24 hours postoperatively

Serum vancomycin concentration

时间窗: 2 hours, 8 hours and 24 hours postoperatively

Renal function

时间窗: Postoperative Day 1 and Day 3

blood urea nitrogen (BUN), creatinine (Cr), GFR

Blood loss

时间窗: Postoperative Day 3

次要结局

未报告次要终点

研究者

发起方

The Affiliated Hospital of Qingdao University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Xiang Shuai, MD

Principal Investigator

The Affiliated Hospital of Qingdao University

研究点 (1)

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