End-Stage Kidney DiseaseNCT03683563
The Impact of Different Citrate Concentrations as Locking Solutions on Development of Biofilm and Function of Hemodialysis Catheters
A study testing 4% sodium citrate and 30% sodium citrate in people with End-Stage Kidney Disease and Renal Dialysis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Kidney Disease, Renal Dialysis, Central Venous Catheter
- What is being tested?
- 4% sodium citrate and 30% sodium citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 Apr 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD on dialisys
- AKI on dialisys
Who cannot join
- systemic bacterial infection at the time of catheter insertion
- local infection at the catheter insertion site
- hypersensitivity to citrate
- pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana, Ljubljana, Slovenia
Ljubljana, 1000
Bojan Medved, MD, +38670609667, bojan.medved@kclj.si
About this study
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
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.
Read the 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.
- Being tested
- 4% sodium citrate, 30% sodium citrate
- Keywords
- Dialysis catheters, Citrate, Locking solution
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% sodium citrateOther
the catheter will be locked with 4% citrate solution after each dialysis session
30% sodium citrateOther
the catheter will be locked with 30% citrate solution after each dialysis session
| Study group | Role | What they receive |
|---|---|---|
| 4% citrate | Active comparator | dialysis catheter locked with 4% sodium citrate Receives: Other: 4% sodium citrate |
| 30% citrate | Experimental | dialysis catheter locked with 30% sodium citrate Receives: Other: 30% sodium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter dysfunction
occurrence of dysfunction of dialysis catheter (expressed as catheter days)
Measured: within 6 months after catheter insertion
Secondary outcomes (2)
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
Measured: 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
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start11 Apr 2018
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bojan Medved, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683563
- Sponsor's protocol ID
- CITRACOMP
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683563
- Acronym / sponsor ID
- CITRACOMP
- Keywords
- Dialysis catheters, Citrate, Locking solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% citrate | Active comparator | Other: 4% sodium citratedialysis catheter locked with 4% sodium citrate |
| 30% citrate | Experimental | Other: 30% sodium citratedialysis catheter locked with 30% sodium citrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD on dialisys
- AKI on dialisys
Key exclusion criteria (4 listed)
- systemic bacterial infection at the time of catheter insertion
- local infection at the catheter insertion site
- hypersensitivity to citrate
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% sodium citratethe catheter will be locked with 4% citrate solution after each dialysis session | Other | 4% citrate |
| 30% sodium citratethe catheter will be locked with 30% citrate solution after each dialysis session | Other | 30% citrate |
Primary outcome
catheter dysfunction
Time frame: within 6 months after catheter insertion
occurrence of dysfunction of dialysis catheter (expressed as catheter days)
2 secondary outcomes
identification of microorganisms
Time frame: an average of 1 year
distribution of biofilm
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% sodium citrate and 30% sodium citrate in people with End-Stage Kidney Disease and Renal Dialysis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bojan Medved, MD (+38670609667, bojan.medved@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter dysfunction (time frame: within 6 months after catheter insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.