Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Prevention of inflammation in hemodialysis patients through hemodialysis catheters
Study Overview
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 .
Detailed Description
In this study,investigators will recruit 60 patients with ESRD on regular hemodialysis from hemodialysis units in Ain-Shams university Hospitals, Patients will be recruited to study at the time of catheter insertion.
They will be randomized into 2 groups. Group 1; 30 Patients will receive unfractionated heparin (5000i.u/ml) after hemodialysis sessions (control group).
Group 2; 30 Patients will receive Taurolock-hep500™ after hemodialysis sessions. All patients will be subjected to;
- Full history including history of ESRD and dialysis initiation.
- Clinical examination. Aseptic technique will be used in handling with catheters including (sterile gloves, antiseptic solution in dealing with covers and caps topical antibiotics spray and ointment) catheter will be instilled by 10 ml of normal saline in both opening followed by either taurolock hep 500™ or unfractionated heparin 5000 iu/ml.
Patients will be followed up for one month and will be monitored for clinical symptoms and signs of catheter related bacteremia (fever ,rigors, hypotension, sweating ) on the hemodialysis sessions . Also catheter performance will be assessed using the following parameters;
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients on regular hemodialysis 3sessions/wk.
- •Recent catheter insertion at beginning of the study.
- •Both males and females.
- •Age group ≥ 18 ys.
Exclusion Criteria
- •Patients with intercurrent infections.
- •Patients with sepsis.
- •Patients receiving drugs affecting immune system like immunosuppressive drugs.
- •Patients on antibiotics.
Arms & Interventions
cases
Cases, taurolidine heparin 500 will be used at end of session
Intervention: Taurolidine heparin (Drug)
control
Controls, Heparin Sodium 5000 will be given at end of session
Intervention: Heparin Sodium (Drug)
Outcomes
Primary Outcomes
Prevention of inflammation in hemodialysis patients through hemodialysis catheters
Time Frame: one month
Comparing levels of highly sensitive c-reactive protein and interleukin-6 levels before and after using the drug Urea reduction ratio over sessions
Secondary Outcomes
No secondary outcomes reported
Investigators
amr mohamed mansour
Assistant Lecturer of nephrology
Ain Shams University