An interventional study of Expanded Hemodialysis and Online Hemodiafiltration in Dialysis Related Complication, Dialysis Hypotension and Hemodialysis-Induced Symptom, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
Hypothesis
Our hypothesis is that HDx is noninferior to olHDF in the following parameters:
Objectives To evaluate each patient, through a prospective, randomized and cross-over study, the intradialytic hemodynamic behavior, fluid and nutritional status assessed by electrical bioimpedance and B2M removal in two dialytic modalities: HDFol versus HDx.
Concise methods
Clinical and laboratorial data Clinical data will be collected from the institution's chart, recorded and filled with all necessary precautions to keep confidentiality of patient's information. They are: baseline renal disease, age, history of smoking, sedentary lifestyle, presence of comorbidities such as hypertension and diabetes mellitus, family history of cardiovascular disease, history of coronary and cerebrovascular disease and medications.
Laboratory tests used to determine the biochemical, hematological and bone mineral profile characteristics will be obtained from routinely collected exams. Such exams are processed by the Central Laboratory of Hospital das Clínicas / FMUSP.
Dialysis All dialysis procedures will be performed by the Dialog+ Admea™ machine (BBraun Melsungen AG, Germany).
The olHDF will be prescribed as follows: blood flow 350 - 400 ml/min, dialysate flow 800 ml/min, post-dilution flow (90-100 ml/min), with high-flux Xevonta™ (BBraun Melsungen AG, Germany) or CAHP/DICE™ (Baxter Healthcare Corporation, Germany) dialyzers, with surface area of 1.7-2.4 m². The duration of each session will be from 3,5h to 4h, depending on current dialysis prescription. Total substitution volume will be higher than 20 L per session.
HDx will follow the same prescription of olHDF, regarding blood and dialysate flows and dialysis duration. There will be no substitution volume. Theranova™ dialyzers (Baxter Healthcare Corporation, Germany) will be used for each session.
Before initiating protocol and during the washout period, patients will be submitted to high-flux HD, which is the standard treatment in our service.
In addition, partial and homogeneous collection of the effluent will be performed by a drainage hose, with an infusion pump operating continuously at a rate of 1l/h. The whole effluent of dialysis session will be collected.
Exclusion Criteria:
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
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
Also known as: Theranova Dialyzer
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.
Medium Molecule Clearance
Beta-2-Microglobulin clearance
Time frame: One month after starting protocol
Medium Molecule Removal
Beta-2-Microglobulin extraction
Time frame: One month after starting protocol
Intradialytic Hemodynamics
noninvasive cardiac output assessment
Time frame: Cardiac output (liters per minute) one month after starting protocol
Fluid Status
noninvasive assessment of extracellular and total body water
Time frame: One month after starting protocol
| Milestone | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Beta-2-Microglobulin clearance
| ml/min | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Medium Molecule Clearance | 53 (41.8 to 63.7) | 59.5 (50.5 to 70) |
Beta-2-Microglobulin extraction
| mg | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Medium Molecule Removal | 198 ± 81 | 239 ± 86 |
noninvasive cardiac output assessment
| l/min | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Intradialytic Hemodynamics | -1.3 (-2.2 to -0.3) | -1.4 (-3 to -1.1) |
noninvasive assessment of extracellular and total body water
| liter/liter | Online Hemodiafiltration | Expanded Hemodialysis |
|---|---|---|
| Fluid Status | 0.39 ± 0.01 | 0.385 ± 0.01 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Online Hemodiafiltration | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Expanded Hemodialysis | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 8 | 15 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| Median | 39.5 (28.7 to 43.5) | 46 (28.7 to 59.5) | 39.5 (28.7 to 52.2) |
| Sex: Female, Male(Participants) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 5 | 6 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 7 | 15 |
| Not Hispanic or Latino | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| Brazil | 8 | 8 | 16 |
| Serum Beta-2 Microglobulin(mcg/ml) | Online Hemodiafiltration | Expanded Hemodialysis | Total |
|---|---|---|---|
| Mean | 23.2 ± 6.9 | 27.8 ± 5.5 | 25.2 ± 6.1 |
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University of Sao Paulo