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

NCT ID: NCT03519360

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-02-01

Brief 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.

Detailed Description

Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.

Following ILR implantation, subjects will alternate between weekly periods in which the ultrafiltration rate can be unlimited or in which the ultrafiltration rate is limited to ≤10mL/kg/hour.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Restricted ultrafiltration rate (UFR)

UFR ≤10 ml/kg/hr

Group Type: EXPERIMENTAL

UFR-restricted dialysis

Intervention Type: OTHER

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.

Standard of Care/ Unrestricted UFR

UFR as needed

Group Type: EXPERIMENTAL

UFR-unrestricted dialysis

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

UFR-unrestricted dialysis

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Maintenance hemodialysis therapy for end-stage renal disease
• Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
• >30 days since dialysis initiation
• Ability to provide informed consent
• Interdialytic weight gain necessitating an UF rate of ≥13mL/kg/hour of dialysis to achieve the target post-dialysis weight in at least half of the dialysis sessions (≥6 sessions) in the month prior to enrollment

Exclusion Criteria

• Expected survival <6 months-to allow trial completion
• Renal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
• Prisoners or cognitive disability preventing informed consent
• Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential >55 years old, women with a history of surgical sterilization, or for women <55 years of age who have not had a menses within the past 12 months
• Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
• Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
• Existing pacemaker, implantable monitor or defibrillator which precludes device placement
• Chronic, persistent AF (defined as the presence of persistent AF on all available EKGs at time of recent screening)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Charytan, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R34HL140477-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017P001737-

Identifier Type: -

Identifier Source: org_study_id