Hemodialysis Catheter Infection Clinical Trial
Official title:
Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.
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 .
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 .
;
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