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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: Acidosis avoidance; Other: Potassium Removal Maximization; Other: Potassium Gradient Minimization; Other: Alkalosis Avoidance; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor

• Registration Number: NCT03519347
• Lead Sponsor: NYU Langone Health

Brief Summary

The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers 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 have 1 month of standard dialysis and will crossover in random order between four month-long periods of dialysis guided by the results of the point of care testing. Whole blood will be obtained by dialysis staff and immediately tested on a point of care chemistry analyzer according to the manufacturer's protocol prior to each dialysis session. The randomized intervention periods will include algorithms that alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium removal as well as a second set of algorithms that alter the bicarbonate bath in order to c) limit acidosis or d) limit alkalosis.

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Study Start: 2018-11-30
• Primary Completion: 2022-07-12
• Study Completion: 2022-10-14
• Status Verified: 2023-07
• Results First Submitted: 2023-07-06
• Results First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Results First Posted: 2023-08-15
• Last Update Posted: 2023-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

• Expected survival <6 monthsRenal 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.
• Hemoglobin <8 g/dL-Serum K >6.5 or <3.5 mEq/L within 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alkalosis Avoidance Strategy	Point of Care Testing	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Acidosis Avoidance Strategy	Acidosis avoidance	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Acidosis Avoidance Strategy	Cardiac Monitor	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Potassium Removal Maximization Strategy	Potassium Removal Maximization	Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Gradient Minimization Strategy	Point of Care Testing	Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization Strategy	Cardiac Monitor	Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Potassium Gradient Minimization Strategy	Potassium Gradient Minimization	Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.
Alkalosis Avoidance Strategy	Cardiac Monitor	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.
Acidosis Avoidance Strategy	Point of Care Testing	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.
Potassium Removal Maximization Strategy	Point of Care Testing	Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Potassium Removal Maximization Strategy	Cardiac Monitor	Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.
Alkalosis Avoidance Strategy	Alkalosis Avoidance	Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.

Primary Outcome Measures

Name	Time	Method
Number of Participants Enrolled Per Month	Up to Week 24	Assessment of recruitment feasibility.
Proportion of Participants Who Experienced Potassium Intervention-Specific Complications	Up to Week 24	Potassium Intervention-Specific Complications are defined as either severe potassium abnormalities (potassium ≥ 6.5 or ≤ 3.0 mEq/L) or unscheduled HD or hospitalization for hyper/hypokalemia in the absence of a missed treatment.
Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications	Up to Week 24	Bicarbonate Intervention-Specific Complications are defined as severe HCO3 abnormalities (HCO3 \<20 or \>32 mEq/L) or unscheduled HD or hospitalization for acid base abnormalities in the absence of a missed treatment.
Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)	Up to Week 24	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.
Adherence With Proposed Interventions	Up to Week 24	Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.

Secondary Outcome Measures

Name	Time	Method
Mean Duration of Atrial Fibrillation	Up to Week 24
Incidence of Potentially Lethal Arrhythmias	Up to Week 24	Potentially lethal arrhythmias defined as asystole, sustained VT, bradycardia for ≥6 seconds.
Cardiovascular Mortality	Up to Week 24	Number of participants who die due to cardiovascular-related causes.
All-Cause Mortality	Up to Week 24	Number of participants who die due to any cause.
Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription	Up to Week 24	The impact of POC testing on trial design will be measured as the percent of sessions in which the POC-guided dialysate prescription differs from a hypothetical prescription in which the choice of dialysate is based solely on the once-monthly lab (usual care).
Incidence of Hospitalization	Up to Week 24
Number of Screened Patients Who Are Enrolled	Up to Week 24	Secondary feasibility measure to assess the size of the necessary screening pool.

Trial Locations

Locations (1)

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States