Citrate Dialysate in Online Hemodialfiltration

Haemodialysis Clinical Trial

Official title:

Comparison of Citrate Dialysate in Predilution and Postdilution Online Hemodiafiltration : Effect on Clot Formation and Adequacy of Dialysis in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280106
• Other study ID #: 080/64
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stable condition
• Having been under HD for at least three months
• he vascular access should have blood flow = 300 mL/min.

Exclusion Criteria:

• no heparin use during HD
• refusal to participate,
• intolerance or allergy to citrate
• concurrent infection
• poor life expectancy due to metastatic cancer, severe cirrhosis and AIDS.
• patients vascular access modification,
• patients affected by chronic liver disease, active neoplastic or inflammatory disease were excluded as well as patients receiving immunosuppressive or anti-inflammatory drugs.

Related Conditions & MeSH terms

• Haemodialysis
• Hemodiafiltration
• Heparin

Intervention

Procedure:
• Pre-dilution online 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
• Post-dilution hemodiafiltration with citrate dialysate
same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.

Locations

Country	Name	City	State
Thailand	Faculty of Medicine ,Vajira Hospital	Bangkok
Thailand	Faculty of Medicine ,Vajira hospital,Navamindradhiraj University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (11)

Aniort J, Petitclerc T, Creput C. Safe use of citric acid-based dialysate and heparin removal in postdilution online hemodiafiltration. Blood Purif. 2012;34(3-4):336-43. doi: 10.1159/000345342. Epub 2013 Jan 9. — View Citation

Canaud B, Bosc JY, Leray H, Stec F, Argiles A, Leblanc M, Mion C. On-line haemodiafiltration: state of the art. Nephrol Dial Transplant. 1998;13 Suppl 5:3-11. doi: 10.1093/ndt/13.suppl_5.3. — View Citation

Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.10 — View Citation

Canaud B, Wizemann V, Pizzarelli F, Greenwood R, Schultze G, Weber C, Falkenhagen D. Cellular interleukin-1 receptor antagonist production in patients receiving on-line haemodiafiltration therapy. Nephrol Dial Transplant. 2001 Nov;16(11):2181-7. doi: 10.1 — View Citation

Carracedo J, Merino A, Nogueras S, Carretero D, Berdud I, Ramirez R, Tetta C, Rodriguez M, Martin-Malo A, Aljama P. On-line hemodiafiltration reduces the proinflammatory CD14+CD16+ monocyte-derived dendritic cells: A prospective, crossover study. J Am Soc — View Citation

Guth HJ, Gruska S, Kraatz G. On-line production of ultrapure substitution fluid reduces TNF-alpha- and IL-6 release in patients on hemodiafiltration therapy. Int J Artif Organs. 2003 Mar;26(3):181-7. doi: 10.1177/039139880302600301. — View Citation

Hottelart C, Achard JM, Moriniere P, Zoghbi F, Dieval J, Fournier A. Heparin-induced hyperkalemia in chronic hemodialysis patients: comparison of low molecular weight and unfractionated heparin. Artif Organs. 1998 Jul;22(7):614-7. doi: 10.1046/j.1525-1594 — View Citation

Kurihara Y, Hosoya H, Kishihara R, Yoshinaga M, Iwadate Y, Yamauchi F, Saito T, Sakurai K. Comparison of the effects of pre-dilution and post-dilution online hemodiafiltration on the levels of inflammatory markers, lymphocytes, and platelets. J Artif Orga — View Citation

Lin CL, Yang CW, Chiang CC, Chang CT, Huang CC. Long-term on-line hemodiafiltration reduces predialysis beta-2-microglobulin levels in chronic hemodialysis patients. Blood Purif. 2001;19(3):301-7. doi: 10.1159/000046958. — View Citation

Thaweethamcharoen T, Srimongkol W, Noparatayaporn P, Jariyayothin P, Sukthinthai N, Aiyasanon N, Kitisriworapan P, Jantarakana K, Vasuvattakul S. Validity and Reliability of KDQOL-36 in Thai Kidney Disease Patient. Value Health Reg Issues. 2013 May;2(1):9 — View Citation

Tsuchida K, Minakuchi J. Clinical benefits of predilution on-line hemodiafiltration. Blood Purif. 2013;35 Suppl 1:18-22. doi: 10.1159/000346221. Epub 2013 Feb 25. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	28 weeks
Secondary	quality of life between pre and post dilution online-hemodiafiltration	KDQOL-sf score;0-100.Higher scores reflect better quality of life	28 weeks
Secondary	adequacy of dialysis between pre and post dilution online-hemodiafiltration	Kt/V	28 weeks
Secondary	calcium level between pre and post dilution online-hemodiafiltration	serum calcium predialysis in midweek of each phase	28 weeks
Secondary	phosphorus level between pre and post dilution online-hemodiafiltration	serum calcium predialysis in midweek of each phase	28 weeks
Secondary	intact parathyroid level between pre and post dilution online-hemodiafiltration	serum parathyroid level in midweek of each phase	28 weeks