Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Catheter Thrombosis; Hemodialysis Catheter Infection
• Intervention / Treatment: Drug: Heparin; Device: Neutrolin

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Heparin group	Drug: Heparin; Heparin hemodialysis catheter lock solution
Experimental: Neotrolin Group	Device: Neutrolin; Neutrolin hemodialysis catheter lock

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)	Rate of hemodialysis catheter in each study arm	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of hemodialysis catheters with poor flow due to thrombosis	Rate of catheter dysfunction in each group	18 month

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 4, 2019
• Primary Completion (Anticipated): October 4, 2020
• Study Completion (Anticipated): April 4, 2021

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: RC17/083/R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No