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

NCT03519347 | Completed Results DMC FDA Device

• 2 other identifiers: 18-01324R34HL140477-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

arrythmia; hemodialysis

Outcome Measures

Primary Outcomes (5)

• Adherence With Proposed Interventions

  Adherence will be assessed as the percent of sessions in which POC testing is completed and the dialysate is adjusted according to the algorithm.

  Up to Week 24

• Number of Participants Enrolled Per Month

  Assessment of recruitment feasibility.

  Up to Week 24

• Proportion of Participants Who Experienced Potassium Intervention-Specific Complications

  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.

  Up to Week 24

• Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications

  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.

  Up to Week 24

• Mean Monthly Duration of Clinically Significant Arrhythmia (CSA)

  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.

  Up to Week 24

Secondary Outcomes (7)

• Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription

  Up to Week 24

• Mean Duration of Atrial Fibrillation

  Up to Week 24

• Incidence of Potentially Lethal Arrhythmias

  Up to Week 24

• Number of Screened Patients Who Are Enrolled

  Up to Week 24

• Incidence of Hospitalization

  Up to Week 24

Study Arms (4)

Potassium Removal Maximization Strategy

EXPERIMENTAL

Dialysate potassium will be adjusted according to the results of point of care testing in order to maximize potassium removal and avoid hyperkalemia.

Other: Potassium Removal Maximization; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor

Potassium Gradient Minimization Strategy

EXPERIMENTAL

Dialysate potassium will be adjusted according to the results of point of care testing in order to minimize the flux of potassium.

Other: Potassium Gradient Minimization; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor

Alkalosis Avoidance Strategy

EXPERIMENTAL

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding alkalosis.

Other: Alkalosis Avoidance; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor

Acidosis Avoidance Strategy

EXPERIMENTAL

Dialysate bicarbonate concentration will be adjusted according to the results of point of care testing in order to prioritize avoiding acidosis.

Other: Acidosis avoidance; Diagnostic Test: Point of Care Testing; Device: Cardiac Monitor

Interventions

Potassium Removal Maximization OTHER

This intervention will test whether prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia reduces the incidence of clinically significant arrhythmias compared to an approach minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.

Potassium Removal Maximization Strategy

Potassium Gradient Minimization OTHER

This intervention will test whether minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients reduces the incidence of clinically significant arrhythmias compared to an approach prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.

Potassium Gradient Minimization Strategy

Alkalosis Avoidance OTHER

The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing alkalosis avoidance by use of lower dialysate HCO3 concentrations.

Alkalosis Avoidance Strategy

Acidosis avoidance OTHER

The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing acidosis avoidance by use of higher dialysate HCO3 concentrations.

Acidosis Avoidance Strategy

Point of Care Testing DIAGNOSTIC_TEST

POC testing will use the Abbott BLUE I-STAT CHEM8+ , a portable, handheld device that provides lab quality analysis within 2-3 minutes using a few drops of whole blood (≤100uL).

Also known as: BLUE I-STAT CHEM8+

Acidosis Avoidance Strategy; Alkalosis Avoidance Strategy; Potassium Gradient Minimization Strategy; Potassium Removal Maximization Strategy

Cardiac Monitor DEVICE

Device is one-third of the size of a triple-A battery and is placed subcutaneously in the left chest during a brief procedure that can be done in-office under local anesthesia.

Also known as: LINQ (Medtronic) Implantable Cardiac Loop Recorder (Carelink System)

Acidosis Avoidance Strategy; Alkalosis Avoidance Strategy; Potassium Gradient Minimization Strategy; Potassium Removal Maximization Strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Duke University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David M Charytan, MD, MSc
• Organization: NYU Langone Health

david.charytan@nyulangone.org

646-501-9086

Study Officials

• David Charytan, MD, MSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: November 30, 2018
• Primary Completion: July 12, 2022
• Study Completion: October 14, 2022
• Last Updated: August 15, 2023
• Results First Posted: August 15, 2023

Record last verified: 2023-07

Locations

US (1)