Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis : A Pilot Study
Copyright © 2022. Published by Elsevier Inc..
RATIONALE & OBJECTIVE: Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD.
STUDY DESIGN: Pilot study.
SETTING & PARTICIPANTS: Adults with estimated glomerular filtration rate (eGFR) ≥5 mL/min/1.73 m2 and urine volume ≥500 mL/d beginning maintenance HD at 14 outpatient dialysis units.
EXPOSURE: Randomized allocation (1:1 ratio) to twice-weekly HD and adjuvant pharmacologic therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or thrice-weekly HD (conventional HD group).
OUTCOME: The primary outcome was feasibility. Secondary outcomes included changes in urine volume and solute clearance.
RESULTS: Of 77 patients invited to participate, 51 consented to do so, representing 66% of eligible patients. We randomized 23 patients to the incremental HD group and 25 patients to the conventional HD group. Protocol-based loop diuretics, sodium bicarbonate, and patiromer were prescribed to 100%, 39%, and 17% of patients on twice-weekly HD, respectively. At a mean follow-up of 281.9 days, participant adherence was 96% to the HD schedule (22 of 23 and 24 of 25 in the incremental and conventional groups, respectively) and 100% in both groups to serial timed urine collection. The incidence rate ratio for all-cause hospitalization was 0.31 (95% CI, 0.08-1.17); and 7 deaths were recorded (1 in the incremental and 6 in the conventional group). At week 24, the incremental HD group had lower declines in urine volume (a difference of 51.0 [95% CI, -0.7 to 102.8] percentage points) and in the averaged urea and creatinine clearances (a difference of 57.9 [95% CI, -22.6 to 138.4] percentage points).
LIMITATIONS: Small sample size, time-limited twice-weekly HD.
CONCLUSIONS: It is feasible to enroll patients beginning maintenance HD into a randomized study of incremental-start HD with adjuvant pharmacotherapy who adhere to the study protocol during follow-up. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental HD with longer twice-weekly HD periods.
FUNDING: Funding was provided by Vifor Inc.
TRIAL REGISTRATION: Registered at ClinicalTrials.gov, identifier NCT03740048.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:80 |
|---|---|
| Enthalten in: |
American journal of kidney diseases : the official journal of the National Kidney Foundation - 80(2022), 2 vom: 01. Aug., Seite 227-240.e1 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Murea, Mariana [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.07.2022 Date Revised 26.01.2023 published: Print-Electronic ClinicalTrials.gov: NCT03740048 Citation Status MEDLINE |
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| doi: |
10.1053/j.ajkd.2021.12.001 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 500 | |a Date Revised 26.01.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03740048 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022. Published by Elsevier Inc. | ||
| 520 | |a RATIONALE & OBJECTIVE: Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD | ||
| 520 | |a STUDY DESIGN: Pilot study | ||
| 520 | |a SETTING & PARTICIPANTS: Adults with estimated glomerular filtration rate (eGFR) ≥5 mL/min/1.73 m2 and urine volume ≥500 mL/d beginning maintenance HD at 14 outpatient dialysis units | ||
| 520 | |a EXPOSURE: Randomized allocation (1:1 ratio) to twice-weekly HD and adjuvant pharmacologic therapy for 6 weeks followed by thrice-weekly HD (incremental HD group) or thrice-weekly HD (conventional HD group) | ||
| 520 | |a OUTCOME: The primary outcome was feasibility. Secondary outcomes included changes in urine volume and solute clearance | ||
| 520 | |a RESULTS: Of 77 patients invited to participate, 51 consented to do so, representing 66% of eligible patients. We randomized 23 patients to the incremental HD group and 25 patients to the conventional HD group. Protocol-based loop diuretics, sodium bicarbonate, and patiromer were prescribed to 100%, 39%, and 17% of patients on twice-weekly HD, respectively. At a mean follow-up of 281.9 days, participant adherence was 96% to the HD schedule (22 of 23 and 24 of 25 in the incremental and conventional groups, respectively) and 100% in both groups to serial timed urine collection. The incidence rate ratio for all-cause hospitalization was 0.31 (95% CI, 0.08-1.17); and 7 deaths were recorded (1 in the incremental and 6 in the conventional group). At week 24, the incremental HD group had lower declines in urine volume (a difference of 51.0 [95% CI, -0.7 to 102.8] percentage points) and in the averaged urea and creatinine clearances (a difference of 57.9 [95% CI, -22.6 to 138.4] percentage points) | ||
| 520 | |a LIMITATIONS: Small sample size, time-limited twice-weekly HD | ||
| 520 | |a CONCLUSIONS: It is feasible to enroll patients beginning maintenance HD into a randomized study of incremental-start HD with adjuvant pharmacotherapy who adhere to the study protocol during follow-up. Larger multicenter clinical trials are indicated to determine the efficacy and safety of incremental HD with longer twice-weekly HD periods | ||
| 520 | |a FUNDING: Funding was provided by Vifor Inc | ||
| 520 | |a TRIAL REGISTRATION: Registered at ClinicalTrials.gov, identifier NCT03740048 | ||
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| 700 | 1 | |a Dressler, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Russell, Gregory B |e verfasserin |4 aut | |
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