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Набор скоро начнётся NCT07637110

Dry Weight Reduction Intervention Via Extra Ultrafiltration

Без фазы С лечением Fluid Accumulation Blood Pressure Management End Stage Renal Disease (ESRD)

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: Ultrafiltration.
Кому может быть актуально
Состояния в реестре: Fluid Accumulation, Blood Pressure Management, End Stage Renal Disease (ESRD). 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
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Обзор

Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations. This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.

Подробное описание

This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of

1. Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks 2. Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.

Вмешательства

  • Процедура Ultrafiltration
    Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.

Первичные конечные точки

  • 24-hour continuous ambulatory blood pressure [Срок оценки: Measurement performed at baseline compared to measurement performed at 24 weeks.]
  • Symptoms of congestion. [Срок оценки: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.]

Критерии участия

Критерии включения

  • Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
  • Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.

OR

  • Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.

Критерии исключения

  • Age <18 years
  • Receiving hemodialysis treatments for acute kidney injury
  • Receiving hemodialysis treatments for less than four weeks
  • Planned switch to peritoneal or home dialysis within next three months
  • Current or planned incremental hemodialysis (less than 3 treatments per week)
  • Current or planned intensive hemodialysis (four or more treatments per week)
  • Scheduled kidney transplantation
  • Major cardiovascular or bleeding event within previous 90 days
  • Receiving chemotherapy or radiation treatment for cancer
  • History of cirrhosis with ascites
  • Inability to complete 24-hour ambulatory blood pressure measurement
  • Wheelchair dependance or other inability to complete six-minute walk test
  • Pre-dialysis systolic blood pressure <100 mmHg
  • Scheduled use of midodrine with hemodialysis treatments
  • History of non-adherence with dialysis treatments
  • Pregnancy
  • Institutionalized
  • Current or pending enrollment in hospice care
  • Inappropriate for enrollment based on investigator or nephrologist discretion

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
  • Northwest Kidney Centers — Seattle

Идентификаторы

NCT: NCT07637110 · STUDY00025083 · R01DK141693

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗