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

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit; Prevention; Lock Solution; Central Venous Catheter Infection; Taurolidine
• Intervention / Treatment: Drug: Saline; Drug: Tigecycline and heparin; Drug: Taurolidine-citrate-heparin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group I; Central venous catheters (CVCs) were locked with 2ml saline as a control group.	Drug: Saline; Central venous catheters (CVCs) were locked with 2ml saline as a control group.
Experimental: Group II; Central venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml.	Drug: Tigecycline and heparin; Central venous catheters (CVCs) were locked with 2ml of a solution comprising tigecycline 5mg/ml and heparin 500 IU/ml.
Experimental: Group III; 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).	Drug: Taurolidine-citrate-heparin; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive bacterial growth	Positive bacterial growth of a swab was recorded.	30 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of mortality	Incidence of mortality was recorded.	30 days after the procedure
Assessment of catheter-related bloodstream infection	Assessment of catheter-related bloodstream infection was recorded.	30 days after the procedure
Assessment of central venous catheter infection	Assessment of central venous catheter (CVC) infection was recorded.	30 days after the procedure
Lenght of intensive care unit stay	Lenght of intensive care unit (ICU) stay was recorded.	30 days after the procedure

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Glycosaminoglycans; Polysaccharides; Naphthacenes; Tetracyclines; Sodium Compounds; Chlorides; Hydrochloric Acid; Tigecycline; Heparin; Sodium Chloride
• Other Study ID Numbers: 36264MD73/4/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No