An interventional study of Pre-dilution online hemodiafiltration with citrate dialysate and Post-dilution hemodiafiltration with citrate dialysate in Hemodiafiltration, Heparin and Haemodialysis, sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital. Completed at 2 sites in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital · Not applicable, Interventional, and Treatment
Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional clearance of medium-size molecules. Furthermore, OL-HDF has been associated with not only better hemodynamic tolerance and biocompatibility , but may even include better survival.with reduction of proinflammatory cytokines and proinflammatory circulating cells , as well as with better control of B2MG levels .Ol-HDF is classified into 2 types according to the mode of addition of the substitution fluid: pre-dilution OL-HDF (pre-HDF) and post-dilution OL-HDF (post-HDF); Post-HDF was associated with significantly higher removal rates of β2-MG than HD. Postdilution HDF is the most effective way to maximize molecule clearance .Post-HDF was associated with significantly higher removal rate of α1-MG, and also significantly higher albumin leakage, than HD and pre-HDF. However, blood concentrations can be elevated using HDF, which can cause thrombosis. On the other hand, predilution HDF can resolve this problem but requires about three times more purified water than postdilution HDF and may not elicit maximal clearance.
Heparin is the most routinely used anticoagulant in hemodialysis. However, it exposes the patient to the risk of bleeding complications and can induce thrombocytopenia. Furthermore, long-term use of heparin induces biological and clinical complications (osteoporosis, dyslipidemia, hyperkalemia) . Regional citrate anticoagulation is a good alternative to heparin use in hemodialysis for patients with increased bleeding risk , but its implementation in bicarbonate hemodialysis (BHD) is laborious and cumbersome: severe side effects can occur due to citrate metabolism and difficulties in adaptation of calcium infusion into the venous line .Therefore, the use of citrate as a dialysis buffer instead of acetate has proven a safe alternative to acetate-containing bicarbonate dialysis and on-line hemodiafiltration without significant hypocalcemia or clinically important coagulation issues.The aim of the present study is the comparison of the patency of the dialyzer ,the quality of life and blood parameters between pre and potdiltuiotn Ol-HDF with citrate dialysate (CD). No study to date has previously compared the use of citrate dialysate between these two modalities in oL-HDF.
Bangkok Metropolitan Administration Medical College and Vajira Hospital is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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The study was conducted for a 28-week period in two phases: For the first 12 weeks, all of the patients were subjected to CD with pre-dilution oL-HDF.After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. The second phase will run after finishing the first phase with the same protocol but with post-dilution online HDF.There will be 2 weeks washout period before starting this phase
Procedure: Pre-dilution online hemodiafiltration with citrate dialysate · Procedure: Post-dilution hemodiafiltration with citrate dialysate
After enrollment, all patients began a 2-week run-in period with conventional dialysis fluid containing acetate and the lowest dose of unfractionated heparin. The investigator titrated the heparin dose by reducing the dose step by step, 25% in each step, until the final minimal dose was achieved. The experimental study consisted of 3 phases, 4 weeks in each phase, and the phases were separated by 1-week washout periods. Phase 1 used CD with 50% of the heparin dose of the baseline. Phases 2 and 3 used 25% heparin and no heparin, respectively. New dialyzers were introduced at the beginning of each phase and the heparin dose was resumed during the washout phase. The calcium concentration in the dialysis fluid was kept constant (1.5 mmol/L) to allow evaluation of the effect of CD on calcium balance
same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.
clotting score between pre and post dilution online-hemodiafiltration
5 grades of clotting score, Grade 1;No or very little residual blood in the filters.Grade 1;Residual blood in less than 10% of the fibers. Grade 2; Residual blood 10-25%. Grade 3; Residual blood 25-50%.Grade 4 ,Residual blood \> 50%
Time frame: 28 weeks
quality of life between pre and post dilution online-hemodiafiltration
KDQOL-sf score;0-100.Higher scores reflect better quality of life
Time frame: 28 weeks
adequacy of dialysis between pre and post dilution online-hemodiafiltration
Kt/V
Time frame: 28 weeks
calcium level between pre and post dilution online-hemodiafiltration
serum calcium predialysis in midweek of each phase
Time frame: 28 weeks
phosphorus level between pre and post dilution online-hemodiafiltration
serum calcium predialysis in midweek of each phase
Time frame: 28 weeks
intact parathyroid level between pre and post dilution online-hemodiafiltration
serum parathyroid level in midweek of each phase
Time frame: 28 weeks
Plan to share: Undecided
Ran from Feb 2022 to primary completion in Sep 2022, 7 months.
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Bangkok Metropolitan Administration Medical College and Vajira Hospital