Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study B
- Conditions
- End Stage Renal Disease
- Interventions
- Other: UFR-restricted dialysisOther: UFR-unrestricted dialysis
- Registration Number
- NCT03519360
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Restricted ultrafiltration rate (UFR) UFR-restricted dialysis UFR ≤10 ml/kg/hr Standard of Care/ Unrestricted UFR UFR-unrestricted dialysis UFR as needed
- Primary Outcome Measures
Name Time Method Change in duration of clinically significant arrhythmia (CSA) per month 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.
Adherence with Proposed Interventions 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 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.
- Secondary Outcome Measures
Name Time Method Comparison of pre- and post-correction adherence 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) 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 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 4 months This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.
All-cause mortality 2 years This measure will assess the effect of the interventions on occurrence of all-cause mortality.
Hospitalization 2 years This measure will assess the effect of the interventions on occurrence of hospitalizations.
Proportion of screened patients enrolled 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.
Cardiovascular mortality 2 years This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States