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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Antimicrobial Locks for Hemodialysis Catheter Infections

NCT07074821

COMPLETED PHASE2

Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis

NCT02618317

Chronic Kidney Disease

COMPLETED PHASE4

The Effectiveness and Safety of 4% Sodium Citrate as a Lock Solution in Central Venous Hemodialysis Catheter

NCT05188339

Central Venous Catheter Thrombosis Renal Dialysis

UNKNOWN PHASE2/PHASE3

Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

NCT02651428

Kidney Failure, Chronic Catheter-Related Infections

COMPLETED PHASE3

Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

NCT01483872

Infection; Dialysis Catheter

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis Catheter Infection Thrombosis; Dialysis Catheter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

comparative

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cases

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

Group Type EXPERIMENTAL

Taurolidine heparin

Intervention Type DRUG

Taurolock-hep 500 at end of session

control

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

Group Type ACTIVE_COMPARATOR

Heparin Sodium

Intervention Type DRUG

Heparin sodium 5000 at end of session

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Taurolidine heparin

Taurolock-hep 500 at end of session

Intervention Type DRUG

Heparin Sodium

Heparin sodium 5000 at end of session

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tautolock HEP 500 Heparin Sodium 5000

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No