Citrate Dialysate in Online Hemodialfiltration

NCT05280106 | Completed DMC

• 1 other identifier: 080/64
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hemodiafiltration; Heparin; Haemodialysis; Citrate Reaction

Keywords

online hemodialfiltration; hemodialysis; citrate; adequacy of dialysis; heparin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• quality of life between pre and post dilution online-hemodiafiltration

  28 weeks

• adequacy of dialysis between pre and post dilution online-hemodiafiltration

  28 weeks

• calcium level between pre and post dilution online-hemodiafiltration

  28 weeks

• phosphorus level between pre and post dilution online-hemodiafiltration

  28 weeks

• intact parathyroid level between pre and post dilution online-hemodiafiltration

  28 weeks

Study Arms (1)

Pre-dilution online hemodiafiltration

EXPERIMENTAL

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

Interventions

Pre-dilution online hemodiafiltration with citrate dialysate PROCEDURE

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

Pre-dilution online hemodiafiltration

Post-dilution hemodiafiltration with citrate dialysate PROCEDURE

same protocol with post-dilution Ol-HDF in these same patients for the later 12 weeks.

Pre-dilution online hemodiafiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (2)

Faculty of Medicine ,Vajira hospital,Navamindradhiraj University

Bangkok, 10300, Thailand

Location

Faculty of Medicine ,Vajira Hospital

Bangkok, 10300, Thailand

Location

Related Publications (11)

• 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):98-102. doi: 10.1016/j.vhri.2013.02.011. Epub 2013 Mar 26.

  PMID: 29702860 RESULT

• 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.

  PMID: 9623523 RESULT

• 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: 10.1038/sj.ki.5000447.

  PMID: 16641921 RESULT

• 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.

  PMID: 12703882 RESULT

• 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: 10.1093/ndt/16.11.2181.

  PMID: 11682665 RESULT

• 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 Nephrol. 2006 Aug;17(8):2315-21. doi: 10.1681/ASN.2006020105. Epub 2006 Jul 6.

  PMID: 16825330 RESULT

• 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.

  PMID: 11244190 RESULT

• 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 Organs. 2022 Mar;25(1):59-65. doi: 10.1007/s10047-021-01281-5. Epub 2021 Jun 14.

  PMID: 34128110 RESULT

• 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.

  PMID: 23466373 RESULT

• 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.1525-1594.1998.06204.x.

  PMID: 9684701 RESULT

• 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.

  PMID: 23306782 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One group interrupted times-series design (ITS)

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: February 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

TH (2)