An interventional study of UFR-restricted dialysis and UFR-unrestricted dialysis in End Stage Renal Disease, sponsored by NYU Langone Health. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
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Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
UFR ≤10 ml/kg/hr
Other: UFR-restricted dialysis
UFR as needed
Other: UFR-unrestricted 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.
UFR's will be unlimited and prescribed according to the standard of care.
Adherence with Proposed Interventions
Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.
Time frame: 2 years
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.
Time frame: 4 months
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.
Time frame: 4 months
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.
Time frame: 2 years
Association of individual interventions with atrial fibrillation (AF)
This measure will assess the effect of the interventions on the duration of atrial fibrillation.
Time frame: 4 months
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.
Time frame: 4 months
The occurrence of clinically significant arrhythmias requiring intervention
This measure will assess the effect of the interventions on occurrence of arrhythmia requiring clinical intervention.
Time frame: 4 months
All-cause mortality
This measure will assess the effect of the interventions on occurrence of all-cause mortality.
Time frame: 2 years
Cardiovascular mortality
This measure will assess the effect of the interventions on occurrence of cardiovascular mortality.
Time frame: 2 years
Hospitalization
This measure will assess the effect of the interventions on occurrence of hospitalizations.
Time frame: 2 years
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.
Time frame: 2 years
Identification of barriers to implementation
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
Association of dialysis day, shift, and site with CSA
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
Association of dialysis day, shift, and site with adherence
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
Association of demographic and pre-randomization factors with adverse events
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
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