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Clinical Trials/NCT03539718
NCT03539718
Unknown
Phase 4

Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.

Ain Shams University1 site in 1 country60 target enrollmentMay 15, 2018

Overview

Phase
Phase 4
Intervention
Taurolidine heparin
Conditions
Hemodialysis Catheter Infection
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
Prevention of inflammation in hemodialysis patients through hemodialysis catheters
Last Updated
7 years ago

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; 1. Full history including history of ESRD and dialysis initiation. 2. 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; 1. Blood flow rate measured by hemodialysis machine blood pump in (ml/min). 2. Dialysis quality by URR( urea reduction ratio) is a dimensionless number used to quantify dialysis treatment adequacy by calculating difference between urea level before and after hemodialysis session (average of 4 sessions , 1 per each week). 3. CBC ,markers of inflammation (CRP) baseline and at time of appearance of symptoms and signs of bacteremia in both groups in addition to (IL6) measured by Elisa technique baseline and at time of appearance of symptoms and signs .

Registry
clinicaltrials.gov
Start Date
May 15, 2018
End Date
February 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

amr mohamed mansour

Assistant Lecturer of nephrology

Ain Shams University

Eligibility Criteria

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

control

Controls, Heparin Sodium 5000 will be given at end of session

Intervention: Heparin Sodium

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

Study Sites (1)

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