NCT07366372

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positive bacterial growth

    Positive bacterial growth of a swab was recorded.

    30 days after the procedure

Secondary Outcomes (4)

  • 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

Study Arms (3)

Group I

PLACEBO COMPARATOR

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

Drug: Saline

Group II

EXPERIMENTAL

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

Drug: Tigecycline and heparin

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).

Drug: Taurolidine-citrate-heparin

Interventions

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).

Group III
SalineDRUG

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

Group I

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

Group II

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Sodium ChlorideTigecyclineHeparin

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesiology, Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

May 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations