Neutrolin Versus Heparin for Locking Hemodialysis Catheters

Hemodialysis Catheter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03425448
• Other study ID #: RC17/083/R
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: April 4, 2021

Study information

• Verified date: March 2019
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: April 4, 2021
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Thrombosis
• Hemodialysis Catheter Infection
• Thrombosis

Intervention

Drug:
• Heparin
Heparin hemodialysis catheter lock solution

Device:
• Neutrolin
Neutrolin hemodialysis catheter lock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)	Rate of hemodialysis catheter in each study arm	18 month
Secondary	Proportion of hemodialysis catheters with poor flow due to thrombosis	Rate of catheter dysfunction in each group	18 month