Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2

Обзор

Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. This study will pilot measuring the patient's residual kidney function at the time of discharge and communicating that result to the accepting nephrologist and the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.

Вмешательства

• Поведенческое Transmission of additional AKI-D recovery information
  Measuring residual kidney function at the time of hospital discharge by timed urine collection (6-24 hours in duration), transmitting the results (urine volume, urea clearance, and creatinine clearance) to the accepting nephrologist and to the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.
• Другое No additional AKI-D recovery information
  The same timed urine collection will be collected at the time of hospital discharge as in the intervention arm, but in the control arm the results will not be transmitted to the accepting nephrologist or to the patient and no information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule will be transmitted. Instead, the research team will call the accepting nephrologist to alert them that this is an AKI-D patient that is being fol

Первичные конечные точки

• Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient. [Срок оценки: Baseline]

Вторичные конечные точки (7)

• Recruitment rate: Number of patients enrolled per month [Срок оценки: Total study duration, anticipated 2 years]
• Screening-to-recruitment ratio: Number of patients who meet inclusion criteria divided by the number of patients enrolled. [Срок оценки: Total study duration, anticipated 2 years]
• Number of post-discharge urine collections completed [Срок оценки: Study day 60]
• Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge [Срок оценки: Study day 60]
• Proportion who recover from needing dialysis [Срок оценки: Study day 60]
• Proportion who trial a <3x/wk hemodialysis schedule but subsequently need to be increased to >= 3x/wk during the 60-day follow-up. [Срок оценки: Study day 60]
• Incidence of adverse events [Срок оценки: Study day 60]

Критерии участия

Критерии включения

• AKI-D (not ESKD, as determined by the clinical inpatient nephrology team)
• Age ≥ 18 years
• Planned for continued dialysis outside the acute hospital setting (at outpatient dialysis unit/SNF/LTACH, not planned transfer to another short-stay acute care hospital).

Критерии исключения

• Pregnant
• Prisoner
• Unable to consent and no surrogate decision maker available
• Clinical team declines to allow approach for study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07106151 · 25-44531 · 5K23DK128605

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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