The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- hospital length of stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion criteria:
- •Patients' family members refuse TCM intervention
排除标准
- 未提供
结局指标
主要结局
hospital length of stay
时间窗: "through study completion, an average of 3 months".
The number of days a patient stays in the hospital
Intensive care unit length of stay
时间窗: "through study completion, an average of 3 months".
the number of days a patient stays in the Intensive care unit
Patient survival and mortality
时间窗: "through study completion, an average of 1 year".
Measure ICU, RCC, and hospital mortality
Mechanical ventilation time
时间窗: "through study completion, an average of 3 months".
The number of days a patient requires mechanical ventilation
Respiratory care center stay
时间窗: "through study completion, an average of 3 months".
The number of days a patient stays in the respiratory care center
次要结局
- PaO2 rate(baseline, day 1-14 of the study)
- Kidney function(baseline, day 1-14 of the study)
- Number of days to reach 100% of target energy expenditure.(baseline, day 1-14 of the study)
- Inspiratory airflow (V')(baseline, day 1-14 of the study)
- Albumin(baseline, day 1-14 of the study)
- total protein(baseline, day 1-14 of the study)
- Creatinine (creatinine)(baseline, day 1-14 of the study)
- Daily urine output(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.(baseline, day 1-14 of the study)
- Oxygenation index(baseline, day 1-14 of the study)
- Number of days to reach 80% of target energy expenditure.(baseline, day 1-14 of the study)
- Respiratory rate (RR)(baseline, day 1-14 of the study)
- Respirator parameters(baseline, day 1-14 of the study)
- Positive end-expiratory pressure (PEEP)(baseline, day 1-14 of the study)
- Alanine transaminase (ALT)(baseline, day 1-14 of the study)
- Liver function(baseline, day 1-14 of the study)
- Alkaline phosphatase (ALP),(baseline, day 1-14 of the study)
- Bilirubin,(baseline, day 1-14 of the study)
- L-lactate dehydrogenase (LD)(baseline, day 1-14 of the study)
- use of vasopressors.(baseline, day 1-14 of the study)
- Prothrombin time (PT)(baseline, day 1-14 of the study)
- Cardiovascular function(baseline, day 1-14 of the study)
- Glasgow Coma Scale (GCS)(baseline, day 1-14 of the study)