Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.

Hemodialysis Catheter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539718
• Other study ID #: taurolock hep 500 efficacy
• Status: Recruiting
• Phase: Phase 4
• Start date: May 15, 2018
• Est. completion date: February 2019

Study information

• Verified date: May 2018
• Source: Ain Shams University
• Contact: Magdy Sharkawy, MD
• Phone: 002010-014-22331
• Email: Magdi35[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients on regular hemodialysis 3sessions/wk.

2. Recent catheter insertion at beginning of the study.

3. Both males and females.

4. Age group = 18 ys.

Exclusion Criteria:

1. Patients with intercurrent infections.

2. Patients with sepsis.

3. Patients receiving drugs affecting immune system like immunosuppressive drugs.

4. Patients on antibiotics.

Related Conditions & MeSH terms

• Hemodialysis Catheter Infection
• Thrombosis
• Thrombosis; Dialysis Catheter

Intervention

Drug:
• Taurolidine heparin
Taurolock-hep 500 at end of session
• Heparin Sodium
Heparin sodium 5000 at end of session

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

FOGARTY, DAMIAN, and PETER MAXWELL.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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