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N/A N=16 Randomized Single-blind Treatment

Expanded Hemodialysis Versus Online Hemodiafiltration

Dialysis Related Complication · Dialysis Hypotension · Hemodialysis-Induced Symptom

Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Medium Molecule Clearance — 53; 59.5 ml/min — p=0.4534

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Expanded Hemodialysis (Device); Online Hemodiafiltration (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Sao Paulo
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Medium Molecule Clearance
53; 59.5 0.4534
PRIMARY
Medium Molecule Removal
198; 239 0.1179
SECONDARY
Intradialytic Hemodynamics
-1.3; -1.4 0.3054

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03274518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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