Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B (RADAR-B)
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|ClinicalTrials.gov Identifier: NCT03519360|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2018
Last Update Posted : May 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Other: UFR-restricted dialysis Other: UFR-unrestricted dialysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: Restricted ultrafiltration rate (UFR)
UFR ≤10 ml/kg/hr
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.
Experimental: Standard of Care/ Unrestricted UFR
UFR as needed
Other: UFR-unrestricted dialysis
UFR's will be unlimited and prescribed according to the standard of care.
- Adherence with Proposed Interventions [ Time Frame: 2 years ]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 [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]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.
- Comparison of pre- and post-correction adherence [ Time Frame: 2 years ]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) [ Time Frame: 4 months ]This measure will assess the effect of the interventions on the duration of atrial fibrillation.
- Association of individual interventions on potentially lethal arrhythmia [ Time Frame: 4 months ]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 [ Time Frame: 4 months ]This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.
- All-cause mortality [ Time Frame: 2 years ]This measure will assess the effect of the interventions on occurrence of all-cause mortality.
- Cardiovascular mortality [ Time Frame: 2 years ]This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.
- Hospitalization [ Time Frame: 2 years ]This measure will assess the effect of the interventions on occurrence of hospitalizations.
- Proportion of screened patients enrolled [ Time Frame: 2 years ]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.
- Identification of barriers to implementation [ Time Frame: 2 years ]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.
- Association of dialysis day, shift, and site with CSA [ Time Frame: 2 years ]Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with CSA.
- Association of dialysis day, shift, and site with adherence [ Time Frame: 2 years ]Exploratory analyses will assess association of dialysis day (Monday/Wednesday/Friday or Tuesday/Thursday/Saturday), shift (1st-3rd), and site with adherence.
- Association of demographic and pre-randomization factors with adverse events [ Time Frame: 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519360
|Contact: David M Charytan, MD, MScemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Patrick Pun, MD 919-672-2464 firstname.lastname@example.org|
|Principal Investigator:||David Charytan, MD, MSc||NYU Langone Health|