Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Not Applicable

• Conditions: Hemodialysis Catheter Infection; Catheter Thrombosis
• Interventions: Device: Neutrolin; Drug: Heparin

• Registration Number: NCT03425448
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05
• Study Start: 2019-04-04
• Primary Completion: 2020-10-04
• Study Completion: 2021-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Neotrolin Group	Neutrolin	-
Heparin group	Heparin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of hemodialysis catheters with poor flow due to thrombosis	18 month	Rate of catheter dysfunction in each group