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

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ClinicalTrials.gov Identifier: NCT03683563

Recruitment Status : Unknown

Verified September 2018 by Bojan Medved, University Medical Centre Ljubljana.
Recruitment status was: Recruiting

First Posted : September 25, 2018

Last Update Posted : September 25, 2018

Sponsor:

Information provided by (Responsible Party):

Bojan Medved, University Medical Centre Ljubljana

Study Description

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.

Condition or disease	Intervention/treatment	Phase
End-Stage Kidney Disease Renal Dialysis Central Venous Catheter Biofilms	Other: 4% sodium citrate Other: 30% sodium citrate	Not Applicable

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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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Prospective, Interventional Study to Investigate the Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters
Actual Study Start Date :	April 11, 2018
Estimated Primary Completion Date :	April 2019
Estimated Study Completion Date :	June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Drug Information available for: Sodium citrate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

catheter dysfunction [ Time Frame: within 6 months after catheter insertion ]
occurrence of dysfunction of dialysis catheter (expressed as catheter days)

Secondary Outcome Measures :

identification of microorganisms [ Time Frame: an average of 1 year ]
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
distribution of biofilm [ Time Frame: an average of 1 year ]
investigators will inspect distribution of biofilm (% area) along inner surface of the dialysis catheter by electronic microscope

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683563

Contacts

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Contact: Bojan Medved, MD	+38670609667	bojan.medved@kclj.si

Locations

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

Sponsors and Collaborators

University Medical Centre Ljubljana

More Information

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Responsible Party:	Bojan Medved, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT03683563
Other Study ID Numbers:	CITRACOMP
First Posted:	September 25, 2018 Key Record Dates
Last Update Posted:	September 25, 2018
Last Verified:	September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Bojan Medved, University Medical Centre Ljubljana:


Dialysis catheters Citrate Locking solution

Additional relevant MeSH terms:

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Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Citric Acid	Sodium Citrate Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

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