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Идёт набор NCT07339202

Preoperative Hemodialysis Timing in Patients With End-Stage Kidney Disease: The POD-ESKD Pilot Trial

Без фазы С лечением Perioperative Management End Stage Kidney Disease (ESRD) Hemodialysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Same-Day Hemodialysis, No Same-Day Hemodialysis.
Кому может быть актуально
Состояния в реестре: Perioperative Management, End Stage Kidney Disease (ESRD), Hemodialysis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to evaluate the feasibility of two different preoperative hemodialysis schedules for people with end-stage kidney disease (ESKD) who undergo surgical procedures. The main questions it aims to answer are: Is it feasible to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Is it safe to randomize participants with ESKD undergoing nonemergent surgical procedures to same-day hemodialysis versus no same-day hemodialysis? Researchers will compare the two hemodialysis schedules to see if the scheduling and safety profiles are the same. Participants will: Answer questions about their health up to 4 weeks before and 4 weeks after the surgical procedure. Receive hemodialysis on the day of the surgical procedure or not, depending on the study treatment assignment.

Подробное описание

Participants will participate in the study for approximately 2 months, including assessment of 30-day postoperative outcomes.

Вмешательства

  • Процедура Same-Day Hemodialysis
    Hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure (typically in the morning prior to the procedure).
  • Процедура No Same-Day Hemodialysis
    No hemodialysis treatment prior to the surgical procedure but on the same calendar day as the surgical procedure.

Первичные конечные точки

  • Number of hours from completion of the most recent preoperative hemodialysis session to entry into the operating room [Срок оценки: up to 1 day]
  • Number of participants who experience electrolyte abnormalities or volume overload requiring additional unplanned hemodialysis, rescheduling / cancellation of the surgical procedure, or an unanticipated escalation of postoperative level of care. [Срок оценки: up to 1 day]

Критерии участия

Критерии включения

  • Patient is willing to comply with all study procedures for the duration of the study
  • Patient has a diagnosis of ESKD
  • Patient initiated hemodialysis at least 90 days prior to the planned surgical procedure
  • Patient is treated with a stable hemodialysis schedule, defined as an average of 2.5- 3.5 hemodialysis sessions per week in the preceding 4 weeks prior to surgery
  • Patient is scheduled to undergo nonemergent surgical procedures in the Stanford Health Care system. This includes (but is not limited to):
  • Fistula or graft creation, revision, or removal
  • Fistulogram
  • Peritoneal dialysis catheter placement or revision
  • Lower extremity angiogram (including femoral and iliac vessels)
  • Lower extremity bypass (including femoral and iliac vessels)
  • Lower extremity amputation
  • Lower extremity endarterectomy (including femoral and iliac vessels) Of note, this list of procedures is not exhaustive and other procedures may be considered that meet inclusion criteria and no exclusion criteria, in consultation with the treatment teams involved.

Критерии исключения

  • Patient is pregnant
  • Patient is a prisoner
  • Patient is < 18 years old
  • The treating clinicians determine that the patient's clinical condition necessitate a specific approach to surgical scheduling or preoperative hemodialysis

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
Лечение

Центры проведения

США · 1 центр
  • Stanford University — Stanford

Публикации

  • Fielding-Singh V, Vanneman MW, Grogan T, Neelankavil JP, Winkelmayer WC, Chang TI, Liu VX, Lin E. Association Between Preoperative Hemodialysis Timing and Postoperative Mortality in Patients With End-stage Kidney Disease. JAMA. 2022 Nov 8;328(18):1837-1848. doi: 10.1001/jama.2022.19626. PMID 36326747
  • Fielding-Singh V, Vanneman MW, Morris AM, Winkelmayer WC, Sun LY, Roshanov PS, Montez-Rath ME, Chertow GM, Lin E. Preoperative Dialysis Dose and Postoperative Outcomes in Patients Receiving Maintenance Hemodialysis. Kidney360. 2025 Nov 1;6(11):1948-1959. doi: 10.34067/KID.0000000874. Epub 2025 Jun 12. PMID 40504620

Идентификаторы

NCT: NCT07339202 · 69235 · 5K23DK138312-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗