Neutrolin Versus Heparin for Locking Hemodialysis Catheters

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03425448

Enrollment

192

Registered

2018-02-07

Start date

2019-04-04

Completion date

2021-04-04

Last updated

2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Thrombosis, Hemodialysis Catheter Infection

Brief summary

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.

Interventions

DRUGHeparin

Heparin hemodialysis catheter lock solution

DEVICENeutrolin

Neutrolin hemodialysis catheter lock

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Multi-center, double-blind, randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026