Neutrolin Versus Heparin for Locking Hemodialysis Catheters

NCT ID: NCT03425448

Last Updated: 2019-03-05

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2021-04-04

Brief Summary

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Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.

Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.

This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.

Detailed Description

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Conditions

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Hemodialysis Catheter Infection Catheter Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Multi-center, double-blind, randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heparin group

Group Type ACTIVE_COMPARATOR

Heparin

Intervention Type DRUG

Heparin hemodialysis catheter lock solution

Neotrolin Group

Group Type EXPERIMENTAL

Neutrolin

Intervention Type DEVICE

Neutrolin hemodialysis catheter lock

Interventions

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Heparin

Heparin hemodialysis catheter lock solution

Intervention Type DRUG

Neutrolin

Neutrolin hemodialysis catheter lock

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* New hemodialysis catheter
* Subject who will need chronic hemodialysis at least twice/week
* Subject likely to require for at least 120 days
* Subject or relative is likely to understand the nature of the study and sign the consent
* Age 18 years and older

Exclusion Criteria

* Subject with unstable malignancy
* Subject with liver cirrhosis with encephalopathy
* Subject know to have allergy to heparin, citrate or traoulidine
* Documented history of arterial thrombosis or known to have hypercoagulable state
* Subjects with active skin infections and ulcers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr. Mubarak Al Abdalla

Consultant Nephrologist and Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RC17/083/R

Identifier Type: -

Identifier Source: org_study_id

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