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Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B

NCT03519360 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-07-22

No results posted yet for this study

Summary

The purpose of this study is to test the feasibility of trials that change the dialysis ultrafiltration rate (UFR) by limiting the maximum rate and to estimate the extent to which limiting the ultrafiltration rate reduces the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

Conditions

Interventions

OTHER

UFR-restricted dialysis

UFR's are limited to a maximum of 10 mL/kg/hr for the duration of the session. In order to prevent progressive volume overload and the need for additional hemodialysis sessions to manage volume gains in this scenario, subjects will crossover weekly between the restricted and unrestricted UFR interventions.

OTHER

UFR-unrestricted dialysis

UFR's will be unlimited and prescribed according to the standard of care.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Duke University

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • David Charytan, MD, MSc · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519360 on ClinicalTrials.gov