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Идёт набор NCT06536231

Hemodynamic Variations During Remote Ischemic Conditioning in Critical Ill Patients

Без фазы С лечением Critical Illness

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: Remote ischemic conditioning.
Кому может быть актуально
Состояния в реестре: Critical Illness. Базовые параметры: 18 лет — 85 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
Литва
Следующий шаг
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Обзор

The main objectives of this study are to evaluate the changes in hemodynamics occurring during the remote ischemic conditioning (RIC) procedure and to compare the hemodynamic responses elicited by passive leg raising before and after the RIC intervention.

Подробное описание

The investigators hypothesized that the inflation of the blood pressure cuff during the remote ischemic conditioning (RIC) procedure would lead to an increase in stroke volume (SV), cardiac index (CI), and peripheral perfusion index and that these changes would correlate with the hemodynamic changes induced by passive leg raising (PLR).

Furthermore, the clinical relevance of the RIC effect in critically ill patients, particularly in terms of determining their hemodynamic responsiveness, remains uncertain. The investigators hypothesized that the RIC procedure influences hemodynamic changes during PLR.

Вмешательства

  • Процедура Remote ischemic conditioning
    Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes.

Первичные конечные точки

  • Maximal change in stroke volume index during remote ischemic conditioning (RIC) procedure [Срок оценки: During RIC procedure]
  • Maximal change in cardiac index during RIC procedure [Срок оценки: During RIC procedure]
  • Maximal change in peripheral perfusion index during RIC procedure [Срок оценки: During RIC procedure]
  • The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during the RIC procedure and those observed during passive leg raising (PLR). [Срок оценки: During RIC procedure, as well as during passive leg raising.]
  • The correlation between the maximal changes in stroke volume index, cardiac index, and peripheral perfusion index observed during PLR before the RIC procedure and those observed during PLR after the RIC procedure. [Срок оценки: During PLR both before and after the RIC procedure.]
Вторичные конечные точки (1)
  • The correlation between the maximum perfusion index (PI), the time to reach maximum PI during cuff release and the maximal changes in stroke volume index, cardiac index and perfusion index observed during PLR. [Срок оценки: During RIC procedure, as well as during PLR.]

Критерии участия

Критерии включения

  • aged over 18 years,
  • admitted to the intensive care unit,
  • monitored with a transpulmonary thermodilution device with calibrated pulse contour analysis (Pulsion Medical Systems, Munich, Germany),
  • decision by the physician in charge to perform passive leg raising.

Критерии исключения

  • pregnancy,
  • advanced malignancy,
  • peripheral artery disease affecting both arms,
  • head trauma,
  • deep vein thrombosis in the lower limbs,
  • intra-abdominal hypertension, defined as an intra-abdominal pressure greater than 12 mmHg.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Литва · 1 центр
  • The Hospital of Lithuanian University of Health Sciences Kauno klinikos, department of Int — Kaunas

Идентификаторы

NCT: NCT06536231 · 1.2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗