Efficacy of Uremic Toxins Clearance With Expanded Hemodialysis
NCT ID: NCT04786535
Last Updated: 2021-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
23 participants
INTERVENTIONAL
2021-05-10
2022-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
And to compare the magnitude of the B2-microglobulin reduction rate based on the type of extracorporeal therapy (ET) used: HDx, HDc, or HDF
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Expanded Hemodialysis Versus High-Volume Online Hemodiafiltration for Uremic Toxin Removal
NCT07348536
Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration
NCT01328119
A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities
NCT06567483
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
NCT04871893
Comparison of Hemodialysis Techniques in the Removal of Uremic Toxins in Chronic Renal Failure
NCT06794216
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The selection of study participants will be consecutive and for convenience
This study will be divided into six periods: three treatment periods (one for each therapy to be compared) and three of "washout" periods (interspersed between the treatment periods). The treatment periods will last four weeks (12 ET sessions, three per week) and will be preceded by a one-week washout period (three ET sessions)
After inclusion in the protocol, participants will be randomly assigned (with the help of a table of random numbers) to one of three ETs to be evaluated (HDc, HDx, or HDF). Afterwards, the first washout period will begin with high-flow conventional hemodialysis (HDc). At the end of the first washout period, the ET randomly assigned to one of three ETs to be evaluated (HDc, HDx, or HDF), following the sequence: Washout 1 -\> Period 1 (HDC, HDx, or HDF) -\> Washout 2 -\> Period 2, etc.
For each period of ET, there will be two sampling times: baseline and final
Blood samples will be obtained through the arterial port of the extracorporeal circuit, at the beginning and at the end of the ET session. The "slow flow" method will be used (UF: 0 mL/min, Qd: 0 mL/min, and Qb: 100 mL/min, for 30 seconds, before extracting the sample from the arterial port) (24). Blood samples will be collected in dry tubes (without anticoagulant) and centrifuged for 10 minutes at 3,000 RPM. The supernatant will be divided into three aliquots and stored at -70°C for further processing.
To calculate sample size, the formula for a noninferiority study was used (Pharmaceutical statistics. 2016;15(1):80-9), which is detailed below:
n= ((r+1) (Z\_(1-β)+Z\_(1-α) )\^2 σ\^2)/(r((μ\_A-μ\_B )-d\_NI )\^2 )
The terms above, are substituted with values obtained from the publication of Kirsch et al. (Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172) as follows:
Objective: Non-inferiority (Ho µA - µB ≤ -dNI vs. µA - µB \> -dNI) Outcome: B2-microglobulin reduction rate. r: allocation ratio by group:1 beta: type II error (90% power):1.2816 alpha: type I error (level of significance 5%):1.960 (variance in the population):1.33 µA - µB (magnitude of the observed effect):80.6 - 78.5 = 2.1 dNI (non-inferiority limit): 3.5
n= ((1+1) (1.2816+1.960)\^2 〖(1.33)〗\^2)/(1((2.1)-3.5)\^2 )= 19, the investigators estimate a 20 % loss in the follow-up , then investigators consider a sample size of n = 23 patients
The nominal variables will be presented in frequencies and proportions. Continuous numerical variables will be analyzed using the Kolmogorov-Smirnov "Z" test to determine their distribution. The results will be shown as the means ± standard deviation in case of normal distribution and as a median with minimum and maximum limits for variables with non-normal distribution.
The total serum concentration of the biochemical variables in general as well as the uremic toxins will be analyzed. Additionally, the reduction rate and purification of the uremic toxins will be analyzed.
The analyses of the inter- and intra-group differences will be performed using the one-way multiple comparisons (ANOVA) method. Post hoc analysis using the Bonferroni method will be used in cases where the groups present a normal distribution; otherwise, the Kruskal-Wallis method will be used. A result with a p \< 0.05 will be considered significant
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hemodiafiltration
Hemodiafiltration
* Single-use high-flux hemodialyzer
* Post-dilution mode
* Minimum convective volume of 23 L
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 700 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
Expanded hemodialysis
Expanded Hemodialysis
* Single-use Theranova 400 Dialyzer
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 500 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
Conventional high-flux hemodialysis
High-flux Conventional Hemodialysis
* Single-use high-flux hemodialyzer
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 500 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Expanded Hemodialysis
* Single-use Theranova 400 Dialyzer
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 500 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
High-flux Conventional Hemodialysis
* Single-use high-flux hemodialyzer
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 500 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
Hemodiafiltration
* Single-use high-flux hemodialyzer
* Post-dilution mode
* Minimum convective volume of 23 L
* Blood flow (Qb) minimum of 300 mL/min
* Dialysis flow (Qd) 700 mL/min
* Minimum therapy time of 4 hours
* Ultrafiltration necessary to achieve dry weight
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Anuric patients (residual urinary volume ≤ 100 mL/24 h)
* Intermittent chronic hemodialysis (three sessions per week, of 3.5 to 4 hours each)
* Without modification of their prescription in the last three months
* Functional arteriovenous fistula, indwelling vascular access (Qb ≥ 300 mL/min), or both
* Letter of acceptance to enter the protocol and a signed informed consent.
Exclusion Criteria
* Active intake or intake in the last six months of immunosuppressants or systemic steroids
* Active autoimmune disease
* Evidence of active systemic infectious event at the time of inclusion or two weeks prior
* Diagnosis of neoplasia or active oncological disease
* Hypoalbuminemia (\< 3.2 g/dL)
* Pregnancy or lactation
* Refusal to participate in the study
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baxter México
UNKNOWN
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ricardo Correa-Rotter, MD
Role: PRINCIPAL_INVESTIGATOR
Head Departament of Nephrology and Mineral Metabolism,
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Belmouaz M, Diolez J, Bauwens M, Duthe F, Ecotiere L, Desport E, Bridoux F. Comparison of hemodialysis with medium cut-off dialyzer and on-line hemodiafiltration on the removal of small and middle-sized molecules . Clin Nephrol. 2018 Jan;89 (2018)(1):50-56. doi: 10.5414/CN109133 .
Ronco C. The Rise of Expanded Hemodialysis. Blood Purif. 2017;44(2):I-VIII. doi: 10.1159/000476012. Epub 2017 May 10.
Ronco C, Marchionna N, Brendolan A, Neri M, Lorenzin A, Martinez Rueda AJ. Expanded haemodialysis: from operational mechanism to clinical results. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii41-iii47. doi: 10.1093/ndt/gfy202.
Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REF.2937
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.