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Идёт набор NCT06452966

The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Без фазы С лечением Organ Failure, Multiple Indigestion Delayed Gastric Emptying Respiratory Failure

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: traditional Chinese medicine, Routine ICU care, historical Routine ICU care.
Кому может быть актуально
Состояния в реестре: Organ Failure, Multiple, Indigestion, Delayed Gastric Emptying, Respiratory Failure. Базовые параметры: от 20 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
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU). The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks. A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Подробное описание

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

A multi center non-randomized real word data study, will include 3 groups: intervention group (n=70), control group (patients recruited enrolled to the ICU during the study period) and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). The intervention group will receive traditional Chinese herbal medicine and/or acupuncture and/or low level laser applied on acupuncture points depending on TCM doctor decision and patient TCM diagnosis. Intervention period will be 2 weeks.

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Вмешательства

  • Другое traditional Chinese medicine
    patients in the group will receive one of or a combination of the following interventions: Oral Chinese medicine decoction: The Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a
  • Другое Routine ICU care
    Patients will receive ICU care
  • Другое historical Routine ICU care
    Patients had received ICU care

Первичные конечные точки

  • Intensive care unit length of stay [Срок оценки: "through study completion, an average of 3 months".]
  • hospital length of stay [Срок оценки: "through study completion, an average of 3 months".]
  • Mechanical ventilation time [Срок оценки: "through study completion, an average of 3 months".]
  • Respiratory care center stay [Срок оценки: "through study completion, an average of 3 months".]
  • Patient survival and mortality [Срок оценки: "through study completion, an average of 1 year".]
Вторичные конечные точки (12)
  • Kidney function [Срок оценки: baseline, day 1-14 of the study]
  • Creatinine (creatinine) [Срок оценки: baseline, day 1-14 of the study]
  • Daily urine output [Срок оценки: baseline, day 1-14 of the study]
  • Number of days out of the first 14 days the patients reach 70% of their target energy expenditure. [Срок оценки: baseline, day 1-14 of the study]
  • Number of days to reach 80% of target energy expenditure. [Срок оценки: baseline, day 1-14 of the study]
  • Number of days to reach 100% of target energy expenditure. [Срок оценки: baseline, day 1-14 of the study]
  • Oxygenation index [Срок оценки: baseline, day 1-14 of the study]
  • PaO2 rate [Срок оценки: baseline, day 1-14 of the study]
  • Respirator parameters [Срок оценки: baseline, day 1-14 of the study]
  • Positive end-expiratory pressure (PEEP) [Срок оценки: baseline, day 1-14 of the study]
  • Respiratory rate (RR) [Срок оценки: baseline, day 1-14 of the study]
  • Inspiratory airflow (V') [Срок оценки: baseline, day 1-14 of the study]

Критерии участия

Критерии включения

  • Age 20 and above
  • Surgical ICU patients
  • The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit

Критерии исключения

  • Patients' family members refuse TCM intervention

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT06452966 · CMUH113-REC3-052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗