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

NCT03519360 | Withdrawn DMC

• 2 other identifiers: 2017P001737-R34HL140477-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

arrythmia; hemodialysis

Outcome Measures

Primary Outcomes (3)

• Adherence with Proposed Interventions

  Adherence will be assessed as the percent of sessions in which the mandated UFR is delivered.

  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.

  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.

  4 months

Secondary Outcomes (8)

• Comparison of pre- and post-correction adherence

  2 years

• Association of individual interventions with atrial fibrillation (AF)

  4 months

• Association of individual interventions on potentially lethal arrhythmia

  4 months

• The occurrence of clinically significant arrhythmias requiring intervention

  4 months

• All-cause mortality

  2 years

Other Outcomes (4)

• Identification of barriers to implementation

  2 years

• Association of dialysis day, shift, and site with CSA

  2 years

• Association of dialysis day, shift, and site with adherence

  2 years

Study Arms (2)

Restricted ultrafiltration rate (UFR)

EXPERIMENTAL

UFR ≤10 ml/kg/hr

Other: UFR-restricted dialysis

Standard of Care/ Unrestricted UFR

EXPERIMENTAL

UFR as needed

Other: UFR-unrestricted dialysis

Interventions

UFR-restricted dialysis OTHER

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.

Restricted ultrafiltration rate (UFR)

UFR-unrestricted dialysis OTHER

UFR's will be unlimited and prescribed according to the standard of care.

Standard of Care/ Unrestricted UFR

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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Duke University Medical Center

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

Study Officials

• David Charytan, MD, MSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: 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: July 1, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)