Expanded Hemodialysis Versus Online Hemodiafiltration

NCT03274518 | Completed Results

• 1 other identifier: 16928
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional hemodialysis (HD) is essential for the treatment of end-stage renal disease (ESRD) patients, by reducing serum concentration of uremic toxins and correcting fluid overload. Nevertheless, HD removes almost exclusively low-range uremic toxins. Therefore, medium-range molecules, such as beta-2-microglobulin might accumulate in tissues, leading to many clinical complications, such as neuropathies, tendinopathies, anemia, bone mineral disease and reduced growth in children. Convective methods might reduce incidence of these complications, by removing molecules of medium-range molecular weight. Online hemodiafiltration (olHDF) is the most extensively used method in this regard. Nevertheless, there are some barriers to the wider introduction of this method in clinical practice, since specific machines are needed for this procedure, the costs with dialysis lines are higher and water consumption increases. More recently, the development of new membranes for hemodialysis allowed removal of medium- and high-range uremic toxins, with albumin retention. Thus, they allow removal of a broad range of uremic toxins, without changing dialysis machine or increasing water consumption. Such therapy is known as expanded hemodialysis (HDx). The aim of this present study is to compare the extraction of middle-size molecules, the hemodynamic behavior, fluid and nutritional status of patients submitted to olHDF or HDx, in a crossover study.

Conditions

Dialysis Related Complication; Dialysis Hypotension; Hemodialysis-Induced Symptom

Keywords

Hemodialysis; Hemodiafiltration; fluid status; hemodynamics

Outcome Measures

Primary Outcomes (2)

• Medium Molecule Clearance

  Beta-2-Microglobulin clearance

  One month after starting protocol

• Medium Molecule Removal

  Beta-2-Microglobulin extraction

  One month after starting protocol

Secondary Outcomes (1)

• Intradialytic Hemodynamics

  Cardiac output (liters per minute) one month after starting protocol

Other Outcomes (1)

• Fluid Status

  One month after starting protocol

Study Arms (2)

Online Hemodiafiltration

ACTIVE COMPARATOR

The olHDF technique combines diffusion with high convection rates in which the dialysis fluid, free of toxins and pyrogens, is used to prepare the replacement fluid. The online module of dialysis machine prepares the replacement fluid by a cold sterilization process. There is a cross-flow water preparation, in order to avoid the accumulation of possible contaminants. The addition of bicarbonate and acid solutions to water follows the process. Next, the ready-for-infusion dialysis solution is passed through another ultrafilter prior to being infused into patients.

Device: Online Hemodiafiltration

Expanded Hemodialysis

EXPERIMENTAL

More recently, membranes with high cutoff values, but with tight pore size distribution have been developed. The main concept is to keep both cutoff and retention onset values close to each other, but with a cutoff value lower than of albumin. This should allow removal of middle-to-high weight range uremic toxins, with very low albumin leak. Thus, these membranes, denominated high retention onset (HRO) membranes, allow performing both diffusive and convective processes in a conventional hemodialysis machine.

Device: Expanded Hemodialysis

Interventions

Expanded Hemodialysis DEVICE

Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month. High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialyzer with online hemodiafiltration

Also known as: Theranova Dialyzer

Expanded Hemodialysis

Online Hemodiafiltration DEVICE

Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month. Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis.

Online Hemodiafiltration

Eligibility Criteria

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

You may qualify if:

• Adult patients who are on maintenance hemodialysis at Hospital das Clínicas and agree to participate in the study by signing the informed consent form.

You may not qualify if:

• Patients who cannot understand or who refuse to sign the informed consent form; Patients who are currently on daily hemodialysis or online hemodiafiltration.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas

São Paulo, 05403-000, Brazil

Location

Related Publications (9)

• Karohl C, de Paiva Paschoal J, de Castro MC, Elias RM, Abensur H, Romao JE Jr, Passlick-Deetjen J, Jorgetti V, Moyses RM. Effects of bone remodelling on calcium mass transfer during haemodialysis. Nephrol Dial Transplant. 2010 Apr;25(4):1244-51. doi: 10.1093/ndt/gfp597. Epub 2010 Jan 29.

  PMID: 20118484 RESULT

• Cheng YL, Shek CC, Wong FK, Choi KS, Chau KF, Ing TS, Li CS. Determination of the solute removal index for urea by using a partial spent dialysate collection method. Am J Kidney Dis. 1998 Jun;31(6):986-90. doi: 10.1053/ajkd.1998.v31.pm9631843.

  PMID: 9631843 RESULT

• Alvares VRC, Ramos CD, Pereira BJ, Pinto AL, Moyses RMA, Gualano B, Elias RM. Pneumatic Compression, But Not Exercise, Can Avoid Intradialytic Hypotension: A Randomized Trial. Am J Nephrol. 2017;45(5):409-416. doi: 10.1159/000471513. Epub 2017 Apr 14.

  PMID: 28407637 RESULT

• Cheng YL, Shek CC, Wong AK, Wong FK, Chau KF, Li CS. A partial dialysate collection method. Int J Artif Organs. 1997 Jan;20(1):14-7.

  PMID: 9062826 RESULT

• Argiles A, Ficheux A, Thomas M, Bosc JY, Kerr PG, Lorho R, Flavier JL, Stec F, Adele C, Leblanc M, Garred LJ, Canaud B, Mion H, Mion CM. Precise quantification of dialysis using continuous sampling of spent dialysate and total dialysate volume measurement. Kidney Int. 1997 Aug;52(2):530-7. doi: 10.1038/ki.1997.364.

  PMID: 9264013 RESULT

• Oliveira CM, Kubrusly M, Mota RS, Silva CA, Choukroun G, Oliveira VN. The phase angle and mass body cell as markers of nutritional status in hemodialysis patients. J Ren Nutr. 2010 Sep;20(5):314-20. doi: 10.1053/j.jrn.2010.01.008. Epub 2010 Mar 19.

  PMID: 20303790 RESULT

• Silva BC, Freitas GR, Silva VB, Abensur H, Luders C, Pereira BJ, de Oliveira RB, Castro MC, Moyses RM, Elias RM. Hemodynamic behavior during hemodialysis: effects of dialysate concentrations of bicarbonate and potassium. Kidney Blood Press Res. 2014;39(5):490-6. doi: 10.1159/000368459. Epub 2014 Nov 23.

  PMID: 25532082 RESULT

• Silva BC, Moyses RM, Silva VB, Freitas GR, Elias RM. Parathyroidectomized patients have impaired capacity of peripheral vascular constriction during hemodialysis. Hemodial Int. 2016 Jan;20(1):50-5. doi: 10.1111/hdi.12309. Epub 2015 Apr 28.

  PMID: 25923250 RESULT

• Jimenez ZN, Silva BC, Reis LD, Castro MC, Ramos CD, Costa-Hong V, Bortolotto LA, Consolim-Colombo F, Dominguez WV, Oliveira IB, Moyses RM, Elias RM. High Dialysate Calcium Concentration May Cause More Sympathetic Stimulus During Hemodialysis. Kidney Blood Press Res. 2016;41(6):978-985. doi: 10.1159/000452601. Epub 2016 Dec 16.

  PMID: 27978518 RESULT

Limitations and Caveats

The sample size was small and trial length was relatively short. We did not directly assessed albumin extraction. Besides, the relatively low ultrafiltration coefficient of both dialyzers limited dialysis performance in all treatment groups.

Results Point of Contact

• Title: Dr. Bruno Caldin da Silva
• Organization: University of São Paulo

bruno.caldin@hc.fm.usp.br

+5511997620521

Study Officials

• Bruno C Silva, PhD

  Renal Division, Unversity of São Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator who collects laboratorial, hemodynamics and bioimpedance data will be blinded for intervention (online hemodiafiltration or expanded hemodialysis)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: September 7, 2017
• Study Start: November 13, 2017
• Primary Completion: October 18, 2018
• Study Completion: March 11, 2019
• Last Updated: September 30, 2019
• Results First Posted: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)