Potassium Flux in Hemodialysis Patients

NCT04287010 | Completed

• 1 other identifier: 201901179
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• To examine and better define the correlation between electrolyte fluctuations, arrhythmia generation, and heart rate variability contributing to cardiovascular morbidity/mortality as described in previous retrospective observational studies.

  This study aims to assess if there is a correlation between serum electrolyte changes and abnormal heart rhythms or heart rate variability

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients based on a limited chart review from the Chromalloy American Kidney Center population will be recruited. These will all be on in center hemodialysis three times per week. Eligible patients based on inclusion/exclusion criteria as listed above will be randomly selected by a random number generator. If selected, they will be invited to participate in the study.

You may qualify if:

• Age \>18 years
• Consistent thrice weekly in center hemodialysis as defined as no missed sessions in the last 30 days.
• Goal Kt/V Urea (\>1.2, which suggests adequate dialysis based on KDOQI guidelines) for at least 3 months
• Serum potassium 3.5-8.0 mEq/L
• Hemoglobin of \>8.0g/dL

You may not qualify if:

• Age \<18 years
• Evidence of residual renal function as defined by \>100mL of urine output per day
• Those whom do not have capacity to consent
• Change in dialysis prescription within the past 30 days
• lead ECG shows non-sinus cardiac rhythm (atrial fibrillation, atrial flutter, or paced rhythm)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington Univeristy in St Louis

St Louis, Missouri, 63110, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine. Nephrology

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: May 21, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)