Renal Dialysis Clinical Trial
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.
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.
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