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Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)

Primary Purpose

End Stage Renal Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UFR-restricted dialysis

UFR-unrestricted dialysis

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring arrythmia, hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Restricted ultrafiltration rate (UFR)

Standard of Care/ Unrestricted UFR

Arm Description

UFR ≤10 ml/kg/hr

UFR as needed

Outcomes

Primary Outcome Measures

Adherence with Proposed Interventions

Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.

Incidence of unscheduled hemodialysis or hospitalization for volume overload

The occurrence of unscheduled hemodialysis or ultrafiltration sessions needed to treat volume overload will be measured to assess the impact of the UFR intervention on the adequacy of volume removal.

Change in duration of clinically significant arrhythmia (CSA) per month

The total monthly duration of CSA (in minutes) will be utilized as the primary efficacy endpoint in comparing this pair of interventions (aggressive vs. conservative UF). In the event of incomplete follow-up, CSA duration will be indexed to follow-up time. CSA will be defined on the basis of arrhythmias likely to lead to sudden cardiac arrest (SCA) or serious morbidity and mortality and will include AF, asystole ≥3 seconds, bradycardia ≤40 beats per minute lasting ≥6 seconds, and sustained VT ≥130 beats per minute lasting ≥30 seconds. CSA's will be adjudicated by study electrophysiologists.

Secondary Outcome Measures

Comparison of pre- and post-correction adherence

This measure will assess adherence to the protocol following any corrective measures made in response to surveys of dialysis staff.

Association of individual interventions with atrial fibrillation (AF)

This measure will assess the effect of the interventions on the duration of atrial fibrillation.

Association of individual interventions on potentially lethal arrhythmia

This measure will assess the effect of the interventions on the duration of potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.

The occurrence of clinically significant arrhythmias requiring intervention

This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.

All-cause mortality

This measure will assess the effect of the interventions on occurrence of all-cause mortality.

Cardiovascular mortality

This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.

Hospitalization

This measure will assess the effect of the interventions on occurrence of hospitalizations.

Proportion of screened patients enrolled

The percent of screened patients enrolled will be calculated as a secondary feasibility measure to assess the size of the necessary screening pool. Reasons for non-enrollment (vis-à-vis inclusion and exclusion criteria and patient and physician preferences) will be assessed to determine the potential for protocol modification to improve recruitment.

Full Information

NCT ID

NCT03519360

First Posted

April 26, 2018

Last Updated

July 15, 2021

Sponsor

NYU Langone Health

Collaborators

National Institutes of Health (NIH), Duke University, National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03519360

Brief Title

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

Acronym

RADAR-B

Official Title

RADAR-B: A Phase 2 Multi-center Study to Evaluate the Safety and Tolerability of Using Point-of-Care-Guided Manipulation of Ultrafiltration Rate to Prevent Hemodialysis-Associated Arrhythmias

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Logistical difficulties with contracting and with local dialysis unit policies preclueded successful recruiting/enrollment

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Institutes of Health (NIH), Duke University, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

arrythmia, hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Restricted ultrafiltration rate (UFR)

Arm Type

Experimental

Arm Description

UFR ≤10 ml/kg/hr

Arm Title

Standard of Care/ Unrestricted UFR

Arm Type

Experimental

Arm Description

UFR as needed

Intervention Type

Other

Intervention Name(s)

UFR-restricted dialysis

Intervention Description

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

Intervention Name(s)

UFR-unrestricted dialysis

Intervention Description

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

Primary Outcome Measure Information:

Title

Adherence with Proposed Interventions

Description

Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.

Time Frame

2 years

Title

Incidence of unscheduled hemodialysis or hospitalization for volume overload

Description

The occurrence of unscheduled hemodialysis or ultrafiltration sessions needed to treat volume overload will be measured to assess the impact of the UFR intervention on the adequacy of volume removal.

Time Frame

4 months

Title

Change in duration of clinically significant arrhythmia (CSA) per month

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Comparison of pre- and post-correction adherence

Description

This measure will assess adherence to the protocol following any corrective measures made in response to surveys of dialysis staff.

Time Frame

2 years

Title

Association of individual interventions with atrial fibrillation (AF)

Description

This measure will assess the effect of the interventions on the duration of atrial fibrillation.

Time Frame

4 months

Title

Association of individual interventions on potentially lethal arrhythmia

Description

This measure will assess the effect of the interventions on the duration of potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.

Time Frame

4 months

Title

The occurrence of clinically significant arrhythmias requiring intervention

Description

This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.

Time Frame

4 months

Title

All-cause mortality

Description

This measure will assess the effect of the interventions on occurrence of all-cause mortality.

Time Frame

2 years

Title

Cardiovascular mortality

Description

This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.

Time Frame

2 years

Title

Hospitalization

Description

This measure will assess the effect of the interventions on occurrence of hospitalizations.

Time Frame

2 years

Title

Proportion of screened patients enrolled

Description

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Identification of barriers to implementation

Description

HD staff and patients will be surveyed once 3 subjects have completed 1 month of each trial and once 6 patients have completed each trial to identify barriers to implementation of the protocol.

Time Frame

2 years

Title

Association of dialysis day, shift, and site with CSA

Description

Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with CSA.

Time Frame

2 years

Title

Association of dialysis day, shift, and site with adherence

Description

Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with adherence.

Time Frame

2 years

Title

Association of demographic and pre-randomization factors with adverse events

Description

Exploratory analyses will assess age, sex, race, mean intra-dialytic weight gain, and mean UFR in month prior to randomization on the incidence of adverse events.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Charytan, MD, MSc

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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