Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04287010 |
Other study ID # |
201901179 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 21, 2019 |
Est. completion date |
November 30, 2020 |
Study information
Verified date |
January 2021 |
Source |
Washington University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Current practice of outpatient hemodialysis entails prescription of standard electrolyte
concentrations based upon patient prescription history and monthly serum electrolyte
measurements. Dialysate concentration of potassium can be adjusted based on standard
available concentrations including 2mmol/L and 3mmol/L. Standard available dialysate
concentration of Magnesium is 0.5mmol/L (which is not ordinarily adjusted further). Potassium
and Magnesium are not routinely measured before or after each dialysis, therefore serum
levels are largely unknown outside of once monthly measurements.
This study aims to further study this correlation of electrolyte fluctuations (potassium and
magnesium) and cardiac arrhythmias/heart rate variability in the ESRD population.
Description:
This is a prospective, cross-sectional study utilizing a study population at Chromalloy
American Kidney Center, an outpatient dialysis unit, which currently serves approximately 150
End Stage Renal Disease (ESRD) patients.
After enrollment, patients will be provided with a schedule for data collection. A standard
12-lead ECG will be performed.A small non-invasive device (MyPatch Holter monitor) will be
attached to each patient's chest before their first weekly dialysis session to measure heart
rhythm and arrhythmia generation. After the recorder is attached, a standard set of bedside
autonomic function tests will be administered. These tests include standing from supine
position, hand grip, Valsalva maneuver and deep breathing.Changes in heart rate, heart
rhythm, and blood pressure in response to these maneuvers will be assessed. The holter
monitor will be worn for the next 92-96 hours and removed after completion of their regular
third weekly dialysis session (Friday or Saturday). The data from these holter monitors will
be analyzed by the Heart Rate Variability Lab at Washington Univeristy. No modifications to
the Holter monitor devices will be made for this study.
Patient vital signs pre/intra/post dialysis by standard protocol will be obtained, including
the following parameters: blood pressure, heart rate, oxygen saturation, relative blood
volume/hematocrit, dialysate flow rate, blood flow rate, ultrafiltration volume.Participant
serum sodium, chloride, potassium, blood urea nitrogen, and magnesium immediately prior to
and after dialysis session will be measured. Participant serum potassium and magnesium levels
every 30 minutes for the first 2 hours of the first weekly dialysis session will be measured
by taking 1mL of blood from the dialysis circuit. Effluent dialysate, which contains no blood
or cellular components, will be collected concurrently with serum sample analysis every 30
minutes during the first weekly dialysis session by taking 10mL of fluid from the dialysate
drain line to be analyzed for sodium, chloride, and potassium. Serum potassium levels will
also be measured immediately prior to and after second and third weekly dialysis sessions by
taking 1mL of blood from dialysis circuit. The capability to draw blood from the dialysis
circuit/tubing has already been incorporated as an industry standard and no modifications to
standard dialysis circuit will be made. This will ensure that the patient will not have any
needle sticks to obtain necessary samples. Obtained serum samples will subsequently be coded
and sent to the Core Lab for Clinical Studies (CLCS) at Washington University for processing
and destruction there after.
All specimens will be assigned a de-identified study code that will be stored in a
secure/locked location separate from collected data. All clinical data obtained will be
de-identified and entered into a datasheet on a Washington University secure encrypted
server. In addition, the Washington University in St. Louis School of Medicine Institute for
Informatics, Informatics Core Services (ICS) will be used for centralized management and
processing of collected data. Washington University in St. Louis belongs to a consortium of
institutional partners that work to maintain a software toolset and workflow for electronic
collection and management of research and clinical trial data. The Research Electronic Data
Capture (REDCap) system will be utilized for data collection and processing in our study. The
REDCap servers are securely housed in an on-site limited access data center managed by the
Research Infrastructure Services at Washington University. All web-based information and
transmission are encrypted with storage on a private, firewall protected network.
Data collected by Holter monitors and serum electrolyte measurements will subsequently be
analyzed by the research team.
Participation in this study will not interfere with regularly scheduled thrice weekly
dialysis treatments and clinic workflow. Nor will participation in this study result in
modification of previously prescribed treatment.