Clinical Trials Logo

Clinical Trial 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 .


Clinical Trial 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 . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03539718
Study type Interventional
Source Ain Shams University
Contact Magdy Sharkawy, MD
Phone 002010-014-22331
Email Magdi35@hotmail.com
Status Recruiting
Phase Phase 4
Start date May 15, 2018
Completion date February 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04054128 - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients Phase 4
Completed NCT03039777 - Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients N/A
Terminated NCT05670964 - Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis N/A
Completed NCT03627884 - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation Phase 4
Recruiting NCT06093269 - Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL) Phase 4
Completed NCT05855616 - Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study N/A
Terminated NCT05228132 - The Pristine Post-Market Study N/A
Completed NCT04967859 - Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis Phase 1
Not yet recruiting NCT03425448 - Neutrolin Versus Heparin for Locking Hemodialysis Catheters N/A
Completed NCT05874219 - Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter Phase 2/Phase 3