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Expanded Hemodialysis Versus Online Hemodiafiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274518
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bruno Caldin da Silva, University of Sao Paulo

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.


Condition or disease Intervention/treatment Phase
Dialysis Related Complication Dialysis Hypotension Hemodialysis-Induced Symptom Device: Expanded Hemodialysis Device: Online Hemodiafiltration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Masking Description: Investigator who collects laboratorial, hemodynamics and bioimpedance data will be blinded for intervention (online hemodiafiltration or expanded hemodialysis)
Primary Purpose: Treatment
Official Title: Expanded Hemodialysis Versus Online Hemodiafiltration: a Pilot Study on Intradialytic Hemodynamics and Fluid Status
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Active Comparator: Online Hemodiafiltration

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

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.


Experimental: Expanded Hemodialysis
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

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

Other Name: Theranova Dialyzer




Primary Outcome Measures :
  1. Medium Molecule Clearance [ Time Frame: One month after starting protocol ]
    Beta-2-Microglobulin clearance

  2. Medium Molecule Removal [ Time Frame: One month after starting protocol ]
    Beta-2-Microglobulin extraction


Secondary Outcome Measures :
  1. Intradialytic Hemodynamics [ Time Frame: Cardiac output (liters per minute) one month after starting protocol ]
    noninvasive cardiac output assessment


Other Outcome Measures:
  1. Fluid Status [ Time Frame: One month after starting protocol ]
    noninvasive assessment of extracellular and total body water



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274518


Locations
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Brazil
Hospital das Clínicas
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Bruno C Silva, PhD Renal Division, Unversity of São Paulo
  Study Documents (Full-Text)

Documents provided by Bruno Caldin da Silva, University of Sao Paulo:
Informed Consent Form  [PDF] October 17, 2018

Publications of Results:

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Responsible Party: Bruno Caldin da Silva, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03274518    
Other Study ID Numbers: 16928
First Posted: September 7, 2017    Key Record Dates
Results First Posted: September 30, 2019
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruno Caldin da Silva, University of Sao Paulo:
Hemodialysis
Hemodiafiltration
fluid status
hemodynamics
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases