Hemodialysis-Induced Symptom Clinical Trial
Official title:
Expanded Hemodialysis Versus Online Hemodiafiltration: a Pilot Study on Intradialytic Hemodynamics and Fluid Status
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:
- Hemodynamic stability
- Nutritional and fluid status
- Removal of beta-2 microglobulin
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
1. 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.
2. 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.
3. Hemodynamic monitoring Cardiac output index (CI), stroke volume (SV - integrated mean of
the flow waveform between the current upstroke and the dichotic notch), peripheral
arterial resistance (PAR - ratio of mean arterial pressure to stroke volume multiplied
by heart rate) and blood pressure (BP) will be accessed by finger beat to-beat monitor
Finometer™ (Finapress Medical Systems BV, Arnhem, The Netherlands), within 15 minutes
after starting olHDF or HDx sessions (predialysis) and again, 15 minutes before its end
(post-dialysis).
4. Bioelectrical impedance Segmental tetrapolar bioelectrical impedance (BIS) will be
performed in all patients while recumbent, before starting study protocol and before
each phase of the study (HDx or olHDF), by the multifrequency InBody™ S10 (Biospace Co.,
Ltd., Korea) device. It allows assessment of the following parameters regarding body
fluids: total body water, total extracellular body water, lower limbs total water
content, lower limbs extracellular water content. Additionally, α-angle, which is a
marker of cellular integrity and nutritional status, will be noted.
5. Blood and Effluent samples Blood samples will be collected pre-session, mid-session and
post-dialysis sessions, both in the first and last dialysis sessions of each of the
periods studied (HDFol or HDx). Pre-session blood samples will be collected immediately
after arteriovenous fistula puncture and the middle and post-session samples will be
collected from the arterial line, 2 minutes after reduction of blood flow to 50 ml/min
and suspension of dialysate flow and/ or replacement.
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.
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