跳至主要内容
临床试验/NCT05458687
NCT05458687Unknown不适用

Traditional Chinese Medicine for Complications in Critically Ill Patients: a Randomized Control Trial

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.

研究概览

简要总结

The purpose of this study was to examine the impact of Chinese medicine on common problems in intensive care units.

详细描述

Introduction

Intensive care unit is a special department in the health care facility. Although with highly development of modern medicine nowadays, the average mortality rate in Intensive care unit is still around 7 to 20 %. There are a few tricky problems that intensivists and intensive care nurses faced very often, including intensive care unit delirium, arrythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Traditional Chinese Medicine can possibly provide a series of interventions that can alleviate those conditions.

Methods: A randomized control trial will examine the effect of traditional Chinese Medicine interventions vs. routine intensive care unit care. The patients will be randomly divided 1:1 into one of two groups. A total of 80 intensive care patient will have to meet the following criteria: age 20-90, two or less inotropic medicine use. Interventions such as: Chinese herbal medicine decoction, acupuncture, laser acupuncture, Chinese Tuina massage, herbal medicinal cake applied on acupoint, health education and diet education, will be given based on the patients needs and Traditional Chinese Medicine doctor decision. The main outcomes will be the incidence of arrythmia, delirium, and poor digestion and the severity of pain. The investigators will also record intensive care unit mortality, intensive care unit stays and hospital days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-90
  • newly intensive care unit admission (<48 hours)
  • Two or less inotropic medicine prescribed

排除标准

  • Clinically unstable: receiving more than inotropic agents.
  • Coagulopathy: Prolong Prothrombin Time、activated Partial Thromboplastin Time more than 4 times

结局指标

主要结局

The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain.

时间窗: ICDSC、RASS、BPS record by everyday.

For delirium use the Intensive Care Delirium Screening Checklist (ICDSC) score of:0\~8. And Richmond Agitation-Sedation Scale (RASS) score of: -5\~+4. For pain use the Behavioral pain scale(BPS) score of:3\~12.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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