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

A Prospective, Interventional Study to Investigate the Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters

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.

Study Overview

• Status: Unknown
• Conditions: End-Stage Kidney Disease; Renal Dialysis; Central Venous Catheter; Biofilms
• Intervention / Treatment: Other: 4% sodium citrate; Other: 30% sodium citrate

Detailed Description

AIM OF THE STUDY:

The aim of the study is to compare the impact of two different concentrations of trisodium 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.

Investigators will compare the influence of two different concentrations of trisodium citrate solutions as a locking solutions for hemodialysis catheters on the formation of intraluminal biofilm, the growth of microorganisms in the lumen of the hemodialysis catheter, and the occurrence of dysfunction of hemodialysis catheters in the same patient at the same time, under the same conditions as the same length and volume of hemodialysis catheters, catheter insertion time, duration of dialysis procedures, sex, age, co-morbidity, therapy and the presence of an infection.

BACKGROUND:

The population of patients this study will include are the ones who are being treated or are supposed to start the hemodialysis treatment at the Center for Acute and Complicated Dialysis, Department for Nephrology, UKC Ljubljana and for vascular approach have newly inserted or for any reason newly replaced two single-hemodialysis catheter to the left or right inner jugular vein.

STUDY DESIGN:

The patients this study will include are the patients on chronic replacement therapy with hemodialysis, patients with acute renal failure who are on transient replacement therapy with hemodialysis and patients with renal failure starting with substitution treatment with chronic hemodialysis.

After determining the eligibility for inclusion in our study, the investigators will acquire the written consent from the patient. Patients that will be included in the study will have simultaneously inserted two jugular catheters. In the inter-dialysis period, catheters will always be filled with one catheter with 30% trisodium citrate solution, another catheter with 4% tri-sodium citrate solution.

The study will be conducted as a prospective interventional clinical trial. After dialysis, the patients' catheters will always be filled by the same protocol (one catheter with 30% trisodium citrate solution, the second catheter with 4% trisodium citrate solution). Patients will be allocated alternately between protocols 1 and 2. There are 2 protocols for filling dialysis catheters: Protocol 1: the upper (artery) catheter will be filled with 4% and lower (vein) with 30% trisodium citrate solution, Protocol 2: upper (artery) catheter will be filled with 30% and the lower (vein) with a 4% trisodium citrate solution.

Among the patients included, investigators will compare the pressure in the extracorporeal system and blood flow through dialysis catheter, time to dysfunction of hemodialysis catheters, eventual infections associated with catheter: bacteremia or sepsis, infection of the exit of dialysis catheters using different concentrations of trisodium citrate as a locking solution in the inter-dialysis period. Among the patients included, investigators will also monitor the duration of dialysis treatment, the duration of the dialysis procedure in one week, the presence of infection, age, co-morbidity, concomitant therapy (treatment with anticoagulation and anti-aggregation drugs, the presence of immunosuppression, antibiotics). In approximately 5 patients we will simultaneously remove the dialysis catheter due to any medical indication and then via an electronic microscope and stereomicroscope evaluate morphological characteristics of biofilm. Investigators will also evaluate the microbiological characteristics of biofilms using microbiological methods.

EXPECTED RESULTS:

It is expected that the occurrence of dysfunction or the number of catheter days in the same patients using different concentrations of trisodium citrate solutions in inter-dialysis period will be statistically different.

It is expected that the morphological parameters of biofilm will be statistically different using different concentration solution of trisodium citrate (30%, 4%). It is also expected that the microbiological characteristics of biofilm will differ according to the used concentration of the trisodium citrate solution in the inter-dialysis period.

The data investigators will receive can help to understand the adverse events occurring with the use of hemodialysis catheters, filling with different concentrations of trisodium citrate solutions.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bojan Medved, MD; Phone Number: +38670609667; Email: bojan.medved@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • University Medical Centre Ljubljana, Ljubljana, Slovenia
    • Contact: Bojan Medved, MD; Phone Number: +38670609667; Email: bojan.medved@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CKD on dialisys
• AKI on dialisys

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4% citrate; dialysis catheter locked with 4% sodium citrate	Other: 4% sodium citrate; the catheter will be locked with 4% citrate solution after each dialysis session
Experimental: 30% citrate; dialysis catheter locked with 30% sodium citrate	Other: 30% sodium citrate; the catheter will be locked with 30% citrate solution after each dialysis session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catheter dysfunction	occurrence of dysfunction of dialysis catheter (expressed as catheter days)	within 6 months after catheter insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identification of microorganisms	investigators will identify potential microorganisms on the surfaces of the hemodialysis catheter by method "sonication" of the catheter segment and afterward cultivation in solid and liquid media	an average of 1 year
distribution of biofilm	investigators will inspect distribution of biofilm (% area) along inner surface of the dialysis catheter by electronic microscope	an average of 1 year

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Citrate; Dialysis catheters; Locking solution
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: CITRACOMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No