Neutrolin Versus Heparin for Locking Hemodialysis Catheters

King Abdullah International Medical Research Center

Status

Unknown

Conditions

Hemodialysis Catheter Infection

Catheter Thrombosis

Treatments

Device: Neutrolin

Drug: Heparin

Study type

Interventional

Funder types

Other

Identifiers

NCT03425448

RC17/083/R

Details and patient eligibility

About

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.

Enrollment

192 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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