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Набор по приглашению NCT06608953

A Prospective Randomized Controlled Trial of Effect of Enhanced External Counter Pulsation to Arterial Stiffness in Chronic Hemodialysis Patient

Без фазы С лечением 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: Enhanced external counterpulsation.
Кому может быть актуально
Состояния в реестре: 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
Таиланд
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 objectives of this study are; * To study effect of Enhanced External Counter Pulsation on arterial stiffness, as measured by pulse wave velocity, compared to standard hemodialysis treatment. * To study effect of Enhanced External Counter Pulsation on central aortic blood pressure compared to standard hemodialysis treatment. * To study effect of Enhanced External Counter Pulsation on cardiac index decline during hemodialysis compared to standard hemodialysis treatment. * To study effect of Enhanced External Counter Pulsation on intradialytic hypotension events compared to standard hemodialysis treatment. * To study effect of Enhanced External Counter Pulsation on blood biomarkers for endothelial dysfunction and vascular inflammation compared to standard hemodialysis treatment. * To identify any adverse events from utilizing Enhanced External Counter Pulsation, such as pain or uncomfortable feeling, or even uncontrol hypertension.

Вмешательства

  • Устройство Enhanced external counterpulsation
    A device applying external pneumatic cuff pressure to the lower limbs, thighs, and buttock sequentially in the diastolic phase synchronouslty with electrocardiography to assist the cardiac function via diastolic augmentation mechanism.

Первичные конечные точки

  • Pulse wave velocity [Срок оценки: Baseline, 1.5 months, and 3 months of research]

Критерии участия

Критерии включения

  • Patients aged 18 years old or older
  • Patients received hemodialysis at King Chulalongkorn Memorial Hospital for at least 3 months
  • Patients received hemodialysis frequency for at least 3 times/week with adequate hemodialysis, named single pool Kt/V of 1.2 or more, as calculated by Chula urea kinetic model
  • Patients achieving proper dry weight, as determined by clinical assessment or by body composition monitoring (Fresineus company)

Критерии исключения

  • Patients with severe or unstable disease required emergent specific treatment such as severe infection or hemodynamic instability
  • Patients with acute coronary syndrome within 1 month
  • Patients received coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within 3 months
  • Patients with severe valvular heart disease and hypertrophic obstructive cardiomyopathy known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
  • Patients with cardiac arrhythmia including atrial fibrillation or atrial flutter known before inclusion or detected by pre - allocation (within 12 months) 12 - lead electrocardiography
  • Patients with known or suspected deep vein thrombosis or peripheral arterial disease
  • Patients with thoracic aortic aneurysm detected pre - allocation (within 12 months) echocardiography or abdominal aortic aneurysm detected by pre - allocation (within 12 months) abdominal ultrasonography
  • Patients with bleeding diathesis other than uremic bleeding, including anticoagulants use, but antiplatelets or local thrombolytics for vascular access stenosis/thrombosis are not included
  • Patients with uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg
  • Patients with severe pulmonary hypertension known before inclusion or detected by pre - allocation (within 12 months) echocardiographic assessment
  • Pregnant patients
  • Patients who not willing to give a consent or who cannot legally give a consent

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
Простое слепое
Основная цель
Лечение

Центры проведения

Таиланд · 1 центр
  • Faculty of Medicine, Chulalongkorn University — Bangkok

Публикации

  • Thongsricome T, Kositanurit W, Siwamogsatham S, Tiranathanagul K. Enhanced external counterpulsation, focusing on its effect on kidney function, and utilization in patients with kidney diseases: a systematic review. Asian Biomed (Res Rev News). 2023 Oct 26;17(5):208-221. doi: 10.2478/abm-2023-0062. eCollection 2023 Oct. PMID 37899762

Идентификаторы

NCT: NCT06608953 · 246/62 · TCTR20220202008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗