Neutrolin Versus Heparin for Locking Hemodialysis Catheters

King Abdullah International Medical Research Center192 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

Hemodialysis Catheter Infection Catheter Thrombosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)

Rate of hemodialysis catheter in each study arm

Time frame: 18 month

Secondary Outcomes

Proportion of hemodialysis catheters with poor flow due to thrombosis

Rate of catheter dysfunction in each group

Time frame: 18 month