Neutrolin Versus Heparin for Locking Hemodialysis Catheters

NCT03425448 | Unknown DMC

• 1 other identifier: RC17/083/R
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemodialysis Catheter Infection; Catheter Thrombosis

Outcome Measures

Primary Outcomes (1)

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

  Rate of hemodialysis catheter in each study arm

  18 month

Secondary Outcomes (1)

• Proportion of hemodialysis catheters with poor flow due to thrombosis

  18 month

Study Arms (2)

Heparin group

ACTIVE COMPARATOR

Drug: Heparin

Neotrolin Group

EXPERIMENTAL

Device: Neutrolin

Interventions

Heparin DRUG

Heparin hemodialysis catheter lock solution

Heparin group

Neutrolin DEVICE

Neutrolin hemodialysis catheter lock

Neotrolin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist and Assistant Professor

Model Details: Multi-center, double-blind, randomized controlled trial

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 7, 2018
• Study Start: April 4, 2019
• Primary Completion: October 4, 2020
• Study Completion: April 4, 2021
• Last Updated: March 5, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share