Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.
Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.
1 other identifier
interventional
60
1 country
1
Brief Summary
To assess the efficacy of Taurolock-hep500™ as anticoagulant and antimicrobial catheter lock solution in comparison to unfractionated heparin as alock solution to improve performance of hemodialysis catheters and quality of hemodialysis .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2018
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
July 31, 2017
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMay 29, 2018
May 1, 2018
6 months
July 31, 2017
May 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of inflammation in hemodialysis patients through hemodialysis catheters
Comparing levels of highly sensitive c-reactive protein and interleukin-6 levels before and after using the drug Urea reduction ratio over sessions
one month
Study Arms (2)
cases
EXPERIMENTALCases, taurolidine heparin 500 will be used at end of session
control
ACTIVE COMPARATORControls, Heparin Sodium 5000 will be given at end of session
Interventions
Eligibility Criteria
You may qualify if:
- Patients on regular hemodialysis 3sessions/wk.
- Recent catheter insertion at beginning of the study.
- Both males and females.
- Age group ≥ 18 ys.
You may not qualify if:
- Patients with intercurrent infections.
- Patients with sepsis.
- Patients receiving drugs affecting immune system like immunosuppressive drugs.
- Patients on antibiotics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospitals
Cairo, 002, Egypt
Related Publications (1)
FOGARTY, DAMIAN, and PETER MAXWELL.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Magdy Sharkawy, MD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer of nephrology
Study Record Dates
First Submitted
July 31, 2017
First Posted
May 29, 2018
Study Start
May 15, 2018
Primary Completion
November 1, 2018
Study Completion
February 1, 2019
Last Updated
May 29, 2018
Record last verified: 2018-05