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Идёт набор NCT07033260

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

— Наблюдательное Intradialytic Hypotension End-Stage Renal Disease Requiring Haemodialysis Uremia; Chronic 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: Non-invasive Monitoring.
Кому может быть актуально
Состояния в реестре: Intradialytic Hypotension, End-Stage Renal Disease Requiring Haemodialysis, Uremia; Chronic, Hemodialysis. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study

Обзор

This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. 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, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.

Вмешательства

  • Другое Non-invasive Monitoring
    All participants will undergo non-invasive ultrasonographic measurement of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) before and during hemodialysis sessions. No treatment or experimental intervention will be applied.

Первичные конечные точки

  • Predictive Value of Carotid Corrected Flow Time (FTc) for Intradialytic Hypotension [Срок оценки: 1 hour after dialysis start during a single session.]
  • Predictive Value of Peak Flow Velocity Variability (PFVV) for Intradialytic Hypotension [Срок оценки: 1 hour after dialysis start during a single session.]
Вторичные конечные точки (2)
  • Incidence of Intradialytic Hypotension [Срок оценки: Up to 1 dialysis session (4 hours)]
  • Correlation Between FTc and PFVV and Changes in Blood Pressure [Срок оценки: 1 hour after dialysis start during a single hemodialysis session (total duration up to 4 hours)]

Критерии участия

Критерии включения

Adults aged 18 to 80 years. Diagnosed with end-stage renal disease (ESRD). Undergoing maintenance hemodialysis for more than three months. Willing and able to provide informed consent and comply with study procedures.

Критерии исключения

Patients with significant carotid artery stenosis due to heavy atherosclerotic plaque (defined as more than 70% stenosis confirmed by ultrasound or angiography).

Hemodynamically unstable patients or those requiring vasopressor support. Patients with significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia).

Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).

Use of antihypertensive medications during dialysis sessions. Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.

Patients who withdraw informed consent during the study.

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

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: NCT07033260 · 2025-12

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗