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

• ClinicalTrials.gov Identifier: NCT03539718
• Recruitment Status: Unknown
• First Posted: May 29, 2018
• Last Update Posted: May 29, 2018
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): amr mohamed mansour, Ain Shams University

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Hemodialysis Catheter Infection; Thrombosis; Dialysis Catheter	Drug: Taurolidine heparin; Drug: Heparin Sodium	Phase 4

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 .

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: comparative
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.
• Actual Study Start Date: May 15, 2018
• Estimated Primary Completion Date: November 2018
• Estimated Study Completion Date: February 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: cases; Cases, taurolidine heparin 500 will be used at end of session	Drug: Taurolidine heparin; Taurolock-hep 500 at end of session; Other Name: Tautolock HEP 500
Active Comparator: control; Controls, Heparin Sodium 5000 will be given at end of session	Drug: Heparin Sodium; Heparin sodium 5000 at end of session; Other Name: Heparin Sodium 5000

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Magdy Sharkawy, MD; 002010-014-22331; Magdi35@hotmail.com

Contact: Amr Mansour, Msc; 00201007212824; Theamr19@gmail.com

Locations

Egypt

Ain Shams University Hospitals; Recruiting

Cairo, Egypt, 002

Contact: amr m mansour, Msc 1007212824 theamr19@gmail.com

Principal Investigator: magdy Mohamed Saeed El Sharkawy, MD

Sponsors and Collaborators

Ain Shams University

Investigators

• Study Director: Magdy Sharkawy, MD; Ain Shams University

More Information

Publications:

FOGARTY, DAMIAN, and PETER MAXWELL.

• Responsible Party: amr mohamed mansour, Assistant Lecturer of nephrology, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03539718
• Other Study ID Numbers: taurolock hep 500 efficacy
• First Posted: May 29, 2018
• Last Update Posted: May 29, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Taurolidine; Heparin; Calcium heparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Infective Agents, Local; Antineoplastic Agents