N/A
Completed N=19
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A
Source: ClinicalTrials.gov NCT03519347 ↗Enrolled (actual)
19
Serious AEs
21.2%
Results posted
Aug 2023
Primary outcomePrimary: Adherence With Proposed Interventions — 88; 90; 83; 80 Percentage of sessions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence With Proposed Interventions |
88; 90; 83; 80 | — |
| PRIMARY Number of Participants Enrolled Per Month |
0.7 | — |
| PRIMARY Proportion of Participants Who Experienced Potassium Intervention-Specific Complications |
0.0062; 0 | — |
| PRIMARY Proportion of Participants Who Experience Bicarbonate Intervention-Specific Complications |
0.17; 0.046 | — |
| PRIMARY Mean Monthly Duration of Clinically Significant Arrhythmia (CSA) |
497; 60.8; 1020; 7950 | — |
| SECONDARY Percent of Sessions in Which POC-Guided Dialysate Prescription Differs From Standard of Care-Guided Prescription |
55.80; 41.20; 90.20; 88.90 | — |
| SECONDARY Mean Duration of Atrial Fibrillation |
1440; 120; 1170; 189 | — |
| SECONDARY Incidence of Potentially Lethal Arrhythmias |
2; 2; 0; 3 | — |
| SECONDARY Number of Screened Patients Who Are Enrolled |
19 | — |
| SECONDARY Incidence of Hospitalization |
3; 4; 2; 3 | — |
| SECONDARY All-Cause Mortality |
1; 0; 1; 2 | — |
| SECONDARY Cardiovascular Mortality |
1; 0; 0; 1 | — |
Eligibility Criteria
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
Exclusion Criteria
- Expected survival 55 years old, women with a history of surgical sterilization, or for women 6.5 or <3.5 mEq/L within 30 days
Data sourced from ClinicalTrials.gov (NCT03519347). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.