Chronic Kidney Disease Clinical Trial
Official title:
CITrate and Evodial for Effective Dialysis (CITED) Study
It is not known whether the combination of a heparin-grafted membrane plus citrate-containing dialysate is a valid alternative to regional citrate anticoagulation. This is a cross-over non-inferiority trial comparing these two anticoagulation strategies
Anticoagulation is one of the supporting pillars of chronic hemodialysis (HD) (1). The
optimal anticoagulant regimen provides full anticoagulation of the extracorporeal circuit
with minimal systemic effects and comes at an affordable cost. Unfractionated heparin (UFH)
has been the standard of care for many years. In several countries, UFH has gradually been
replaced by low molecular weight heparins (LMWH). LMWH are easy to use as they can be
administered as a bolus injection and reduce membrane fibrin and platelet deposition (2,1).
Both UFH or LMWH provide adequate anticoagulation of the extracorporeal circuit, at the
price of systemic anticoagulation. Apart from bleeding, the administration of unfractionated
heparins has also been associated with dyslipidemia, hypoaldosteronism and hyperkalemia,
thrombopenia, osteoporosis, pruritus, and hypersensitivity reactions.
Several alternative anticoagulation regimens have been proposed including heparin coating of
the dialyzer membrane and regional citrate anticoagulation. Regional citrate anticoagulation
is performed by infusing citrate into the arterial line of the dialysis tubing to reduce
ionized calcium concentrations to very low levels (4,1). Ionized calcium concentrations are
restored by calcium supplementation prior to reinfusion of the blood into the patient. Most
often, calcium repletion is by calcium infusion into the venous line. Alternatively, a
conventional calcium containing dialysate will restore calcium concentrations and, although
the anticoagulant effect is blunted in the venous line, gives acceptable results (5). A
previous study suggested that regional citrate anticoagulation is superior to heparin-coated
polyacrylonitrile dialyzers (AN69ST; Nephral 300ST, Gambro) and resulted in in significantly
greater instantaneous urea nitrogen clearances (3).
While generally safe and adequate, regional citrate anticoagulation requires additional
actions during preparatory phase (preparation of citrate and calcium infusion pumps) as well
as during the treatment (measurement of ionized calcium). These additional actions result in
additional costs.
Recently, acetate-free citrate-containing dialysate concentrates were introduced into
clinical practice. Besides the advantages of acetate-free dialysate, this provides a modest
local anticoagulant effect inside the dialyzer. Citrate-containing dialysate allowed to
reduce heparin dose while maintaining extracorporeal circuit patency and dialyzer clearances
(6).
The investigators questioned whether combination of citrate-containing dialysate and
heparin-coated dialyzer membranes is equally effective as conventional regional citrate
anticoagulation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05491642 -
A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses
|
Phase 1 | |
Recruiting |
NCT06363097 -
Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
|
||
Terminated |
NCT04043026 -
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
|
||
Completed |
NCT05318014 -
Low-protein Formula Supplements in Chronic Kidney Disease
|
N/A | |
Active, not recruiting |
NCT06071065 -
Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients
|
N/A | |
Completed |
NCT02878317 -
Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
|
||
Not yet recruiting |
NCT06039254 -
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
|
Phase 1 | |
Recruiting |
NCT03160326 -
The QUALITY Vets Project: Muscle Quality and Kidney Disease
|
||
Completed |
NCT02875886 -
DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease
|
Phase 4 | |
Completed |
NCT02896309 -
The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity
|
N/A | |
Completed |
NCT02836574 -
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
|
Phase 2 | |
Completed |
NCT02756520 -
Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
|
||
Withdrawn |
NCT02885545 -
The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial
|
Phase 4 | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Active, not recruiting |
NCT02483039 -
Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization
|
N/A | |
Terminated |
NCT02543177 -
Optimised Procedure in Patients With NSTEMI and CKD
|
N/A | |
Completed |
NCT02369549 -
Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease
|
Phase 3 | |
Completed |
NCT02992548 -
Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
|
Phase 4 | |
Recruiting |
NCT02205944 -
Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes
|
N/A | |
Active, not recruiting |
NCT02231138 -
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease
|
Phase 4 |