The Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters

NCT03683563 | Unknown

• 1 other identifier: CITRACOMP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evidence that supports using certain concentration of trisodium citrate as a locking solution for hemodialysis catheters has not yet been established. Higher concentrations of trisodium citrate are more effective in preventing thrombosis, formation of blood clots, preventing infections and biofilm formation, but due to potential side effects, their use is limited. The aim of the study is to compare the impact of two different concentrations of tri-sodium citrate solution (30% and 4%) on the formation of biofilms in hemodialysis single-volume jugular hemodialysis catheters and to determine the effectiveness of prevention of dysfunction of hemodialysis catheters.

Conditions

End-Stage Kidney Disease; Renal Dialysis; Central Venous Catheter; Biofilms

Keywords

Dialysis catheters; Citrate; Locking solution

Outcome Measures

Primary Outcomes (1)

• catheter dysfunction

  occurrence of dysfunction of dialysis catheter (expressed as catheter days)

  within 6 months after catheter insertion

Secondary Outcomes (2)

• identification of microorganisms

  an average of 1 year

• distribution of biofilm

  an average of 1 year

Study Arms (2)

4% citrate

ACTIVE COMPARATOR

dialysis catheter locked with 4% sodium citrate

Other: 4% sodium citrate

30% citrate

EXPERIMENTAL

dialysis catheter locked with 30% sodium citrate

Other: 30% sodium citrate

Interventions

4% sodium citrate OTHER

the catheter will be locked with 4% citrate solution after each dialysis session

4% citrate

30% sodium citrate OTHER

the catheter will be locked with 30% citrate solution after each dialysis session

30% citrate

Eligibility Criteria

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

You may qualify if:

• CKD on dialisys
• AKI on dialisys

You may not qualify if:

• systemic bacterial infection at the time of catheter insertion
• local infection at the catheter insertion site
• hypersensitivity to citrate
• pregnancy

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Sodium Citrate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Bojan Medved, MD

CONTACT

+38670609667; bojan.medved@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: April 11, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

SL (1)