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

Primary Purpose

Hemodialysis Catheter Infection, Thrombosis; Dialysis Catheter

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Taurolidine heparin
Heparin Sodium
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemodialysis Catheter Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cases

control

Arm Description

Cases, taurolidine heparin 500 will be used at end of session

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2017
Last Updated
May 16, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03539718
Brief Title
Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters.
Official Title
Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 .
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; Full history including history of ESRD and dialysis initiation. 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; Blood flow rate measured by hemodialysis machine blood pump in (ml/min). 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). 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Catheter Infection, Thrombosis; Dialysis Catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
comparative
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cases
Arm Type
Experimental
Arm Description
Cases, taurolidine heparin 500 will be used at end of session
Arm Title
control
Arm Type
Active Comparator
Arm Description
Controls, Heparin Sodium 5000 will be given at end of session
Intervention Type
Drug
Intervention Name(s)
Taurolidine heparin
Other Intervention Name(s)
Tautolock HEP 500
Intervention Description
Taurolock-hep 500 at end of session
Intervention Type
Drug
Intervention Name(s)
Heparin Sodium
Other Intervention Name(s)
Heparin Sodium 5000
Intervention Description
Heparin sodium 5000 at end of session
Primary Outcome Measure Information:
Title
Prevention of inflammation in hemodialysis patients through hemodialysis catheters
Description
Comparing levels of highly sensitive c-reactive protein and interleukin-6 levels before and after using the drug Urea reduction ratio over sessions
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdy Sharkawy, MD
Phone
002010-014-22331
Email
Magdi35@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Mansour, Msc
Phone
00201007212824
Email
Theamr19@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy Sharkawy, MD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amr m mansour, Msc
Phone
1007212824
Email
theamr19@gmail.com
First Name & Middle Initial & Last Name & Degree
magdy Mohamed Saeed El Sharkawy, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
FOGARTY, DAMIAN, and PETER MAXWELL.
Results Reference
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Learn more about this trial

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

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