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Идёт набор NCT07033273

Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

— Наблюдательное End-Stage Renal Disease Requiring Haemodialysis Intradialytic Hypotension

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: Non-invasive Monitoring.
Кому может быть актуально
Состояния в реестре: End-Stage Renal Disease Requiring Haemodialysis, Intradialytic Hypotension. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud

Обзор

This multicenter, prospective observational study aims to evaluate the predictive value of the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded. Ultrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.

Вмешательства

  • Другое Non-invasive Monitoring
    All participants will undergo non-invasive measurement of Inferior Vena Cava Collapsibility Index (IVCCI) using ultrasound and routine blood pressure monitoring before and during hemodialysis sessions. No treatment or experimental intervention will be applied.

Первичные конечные точки

  • Predictive Value of IVCCI at 1 Hour for Intradialytic Hypotension [Срок оценки: 1 hour after dialysis initiation]
  • Predictive Value of IVCmax at 1 Hour for Intradialytic Hypotension [Срок оценки: 1 hour after dialysis initiation]
  • Predictive Value of IVCmin at 1 Hour for Intradialytic Hypotension [Срок оценки: 1 hour after dialysis initiation.]
Вторичные конечные точки (2)
  • Incidence of Intradialytic Hypotension [Срок оценки: Up to one dialysis session (4 hours)]
  • Correlation Between IVC Parameters and Blood Pressure Changes [Срок оценки: Up to one dialysis session (4 hours)]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • Diagnosed with end-stage renal disease (ESRD).
  • Undergoing regular hemodialysis for at least three months.

Критерии исключения

  • Pregnant or breastfeeding women.
  • Hemodynamically unstable patients or those requiring vasopressor support.
  • Patients with severe cardiac conditions, including congestive heart failure -classified as NYHA Class III-IV or severe valvular disease.
  • Patients with known allergies to dialysis filters.
  • Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).
  • Patients who withdraw informed consent during the study.
  • Use of antihypertensive medications during dialysis sessions.
  • Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medic — Wuhu

Идентификаторы

NCT: NCT07033273 · 2025-37

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗