Меню
Идёт набор NCT07022847

Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

— Наблюдательное Hypotension and Shock Hemodialysis 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: Hypotension and Shock, Hemodialysis, 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study

Обзор

What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken. Who can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months. Those who are willing and able to participate and sign an informed consent form. Who cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable. Patients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures. What will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins. Blood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session. Data Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded. What are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future. Risks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care. Your Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care. The study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.

Вмешательства

  • Другое Non-invasive Monitoring
    All participants will undergo non-invasive measurement of Pleth Variability Index (PVI) and routine blood pressure monitoring before and during hemodialysis sessions. No treatment or experimental intervention will be applied.

Первичные конечные точки

  • Predictive Value of PVI for Intradialytic Hypotension [Срок оценки: Pre-dialysis (baseline), and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).]
  • Predictive Value of Percentage Change in Pleth Variability Index (%PVi) for Intradialytic Hypotension [Срок оценки: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).]
Вторичные конечные точки (3)
  • Incidence of Intradialytic Hypotension [Срок оценки: Up to 1 dialysis session (4 hours)]
  • Predictive Value of Change in Pleth Variability Index (dPVi) for Intradialytic Hypotension [Срок оценки: From pre-dialysis (baseline) to 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).]
  • Correlation Between PVI, dPVi, %PVi and Changes in Blood Pressure [Срок оценки: Pre-dialysis (baseline) and 60 minutes after the start of a single hemodialysis session (total duration up to 4 hours).]

Критерии участия

Критерии включения

  • Adults aged 18 to 80 years.
  • Diagnosis of end-stage renal disease and undergoing maintenance hemodialysis for more than 3 months.
  • Able and willing to provide informed consent and comply with study procedures.

Критерии исключения

  • Severe cardiac arrhythmias or significant peripheral vascular disease that may interfere with PVI measurements.
  • Local edema, skin lesions, or other conditions that prevent accurate PVI monitoring.
  • History of hemodynamic instability unrelated to dialysis.
  • Pregnant or breastfeeding women.
  • Known allergy or contraindication to materials used in the hemodialysis circuit.
  • Unable to cooperate with study procedures.
  • Participation in another interventional clinical study within the past 30 days.

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: NCT07022847 · 2025-61

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗