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临床试验/NCT07366372
NCT07366372已完成不适用

The Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Positive bacterial growth

研究概览

简要总结

This study aimed to assess effectiveness of a taurolidine based lock solution in preventing the infections of central venous catheter (CVC) in intensive care unit (ICU) cases.

详细描述

The central venous catheter (CVC) is highly frequent in the intensive care unit (ICU), with an average use rate between 32% and 80% among adult ICU patients. The utilization of CVC in ICUs has escalated over the past decade, accompanied by a corresponding increase in problems related to their usage.

Taurolidine is a nontoxic substance having antibacterial impacts counter to mutually gram-positive and -negative bacteria, additionally to fungus. It decreases biofilm development and doesn't develop resistance to antibiotics, since it serves as an antiseptic rather than an antibiotic Consequently, it may function as a locking mechanism.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 21 years.
  • Both genders.
  • Patients admitted to the intensive care unit (ICU) requiring central venous catheter insertion.

排除标准

  • Cases with active infections, hemorrhage or bleeding disorders, infections within insertion place.
  • History of allergy to taurolidine, tigecycline, heparin, and citrate.

研究组 & 干预措施

Group I

Placebo Comparator

Central venous catheters (CVCs) were locked with 2ml saline as a control group.

干预措施: Saline (Drug)

Group II

Experimental

Central venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml.

干预措施: Tigecycline and heparin (Drug)

Group III

Experimental

Central venous catheters (CVCs) were locked with 2ml of a solution containing taurolidine-citrate-heparin (1.35% taurolidine, 4% citrate, and 500 IU/ml heparin).

干预措施: Taurolidine-citrate-heparin (Drug)

结局指标

主要结局

Positive bacterial growth

时间窗: 30 days after the procedure

Positive bacterial growth of a swab was recorded.

次要结局

  • Assessment of catheter-related bloodstream infection(30 days after the procedure)
  • Assessment of central venous catheter infection(30 days after the procedure)
  • Lenght of intensive care unit stay(30 days after the procedure)
  • Incidence of mortality(30 days after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Kelany Zakaria Ibrahim

Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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