Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03929471 |
Other study ID # |
Pro00086730 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
July 1, 2020 |
Study information
Verified date |
February 2022 |
Source |
University of Alberta |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Title of the study: Target weight correction and vascular stiffness in hemodialysis patients
Study design: Randomized clinical trial in the study centre at two locations
Applied medical device:
1. Body Composition Monitor' (BCM, Fresenius) to measure fluid volume overload.
2. Arteriograph 24 (Tensiomed, Budapest, Hungry) to assess vascular stiffness before,
during and after the intervention.
Study hypothesis: A protocolized adjustment of target weight guided by bio-impedance
spectroscopy will improve fluid status, systolic and diastolic blood pressure, and reduce the
arterial wall stiffness without increasing the prevalence of intradialytic hypotension.
Aim of the study:
1. To demonstrate improvement in fluid status by a target weight correction protocol which
applies BCM measurements.
2. To demonstrate that better fluid volume control is associated with a) improvement in
vascular health as assessed by pulse wave velocity and augmentation index and b)
reduction in antihypertensive medications use.
3. To show that this approach does not lead to more episodes with intradialytic
hypotension.
The number of patients: 70 patients
Description:
This study proposal is looking at the application of an accurate assessment of fluid status
in hemodialysis (HD) patients to correct fluid overload. Patients undergoing hemodialysis
suffer from the inability to maintain their normal body fluids and have a high probability to
develop hypertension at initiation of dialysis (1). Long-standing fluid overload is no longer
linked solely to high blood pressure, but also to vascular dysfunction and heart failure (1).
Fluid overload is estimated based on the amount of fluids available outside the cells
(extracellular fluid volume, ECFV). Thus, determination of the right amount of fluid removal
during the dialysis depends on the weight of the patient when the ECFV is normal (referred to
as Target Weight, TW). Essentially, TW is assessed by routine clinical judgment, for example,
leg and hands swelling (edema), elevation in blood pressure and the expansion of the external
jugular vein. Unfortunately, this clinical judgment is not reliable to assess fluid status
(2, 3); hence, overestimation of TW occurs and leads to fluid overload. Current technology
allows assessing fluid overload accurately by using bio-impedance, a non-invasive method that
can be easily used in the HD setting. Despite this, very few studies have been reported where
a systematic approach was followed to use bio-impedance to correct a TW that has been set too
high, with the ultimate goal to correct fluid overload. Therefore, this study aims to provide
better fluid control through an intervention to improve fluid status toward normovolemia by
using bio-impedance assessment of fluid overload rather than clinical judgments. First, the
fluid status will be measured in all study participants by multifrequency bio-impedance using
a 'Body Composition Monitor' (BCM, Fresenius). Second, we will divide the study subjects into
two groups; the control group which will initially receive standard conventional therapy (no
intervention) for 3 months, and the intervention group will undergo by BCM measurements and
integrated TW correction protocol for 3 months. Third, after three months, the control group
will also involve in the same TW correction adjustment. The Primary outcome is improvement in
fluid status towards normovolemia (<1.1 L fluid overload). Secondary outcomes are a)
improvement in vascular health as assessed by pulse wave velocity and augmentation index and
b) a decrease in the use of antihypertensive medications. Altogether, an optimized fluid
status via implemented fluid management plan will provide better control of fluid overload,
blood pressure, and improvement in vascular function.