Effects of Compound Ejiao Syrup on Exercise Tolerance and Quality of Life in Critically Ill Patients After ICU Discharge: A Double-Blind, Multicenter,Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- 6-minute walk test (6MWT)
研究概览
简要总结
This study, titled "Effect of Compound Ejiao Jiang on Exercise Tolerance and Quality of Life of Critically Ill Patients after Discharge from ICU: A Double-Blind, Multicenter, Randomized Controlled Clinical Study (LIFT Study)," intends to enroll 156 patients (78 in the experimental group and 78 in the control group). A double-blind design will be adopted, with patients receiving Compound Ejiao Jiang (20 ml each time, three times a day for 90 consecutive days) or a placebo for intervention. The primary outcome measure is the 6-minute walking distance on the 90th day after randomization. Meanwhile, secondary endpoints such as physical function, quality of life, and nutritional and inflammatory indicators will also be monitored. The aim of this study is to explore the rehabilitation value of Compound Ejiao Jiang for patients with post-intensive care syndrome (PICS) through high-level evidence-based medicine methods and to provide scientific evidence for the integrated traditional Chinese and Western medicine approach to improving the long-term prognosis of critically ill patients
详细描述
This study aims to systematically evaluate the impact of the traditional Chinese medicine compound Ejiao Jiang on the long - term rehabilitation outcomes of critically ill patients after leaving the ICU through a rigorous double - blind, multi - center randomized controlled design, and provide scientific evidence for the improvement of the prognosis of critically ill patients through the combination of traditional Chinese and Western medicine. The following is a detailed breakdown of the protocol:
I. Basic Information of the Study Study Type: Multi - center, double - blind, randomized controlled trial. Study Period: From September 2025 to September 2027, covering the entire process of patient enrollment, follow - up, and data collation.
Sample Size: It is planned to include 156 eligible patients, who will be randomly assigned to the experimental group (78 cases) and the control group (78 cases) at a 1:1 ratio. The sample size calculation is based on the pre - experimental results of the primary endpoint (6 - minute walk distance).
II. Study Objectives
To evaluate the improvement effect of Ejiao Jiang on the exercise tolerance and quality of life of critically ill patients after leaving the ICU, specifically including:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Obtain informed consent;
- •Age between 18 and 75 years (inclusive);
- •Discharged from the ICU within 24 hours;
- •Received mechanical ventilation for at least 48 hours during this ICU stay;
- •Has been in the ICU for at least 8 days but no more than 28 days;
- •Enteral nutrition has been initiated.
- •Able to breathe spontaneously, with an oxygenation index (PaO2/FiO2) ≥ 200, and not requiring continuous high-flow oxygen therapy (e.g., nasal cannula flow ≤ 5 L/min);
- •Glasgow Coma Scale (GCS) score ≥ 13 at ICU discharge, and able to cooperate with study-related tests and follow-up;
- •Able to perform simple bedside activities with assistance (e.g., sitting up, standing, or short-distance walking);
- •No severe heart failure, no end-stage chronic respiratory failure, no lower-limb conditions that impair mobility, and no severe central nervous system disease; Able to stand independently and expected to complete the 6MWT at follow-up.
排除标准
- •1. Patients expected to die or for whom life-sustaining treatment will be withdrawn within 48 hours after ICU discharge;
- •Patients who need to be readmitted to the ICU within 1 week after ICU discharge;
- •Patients with persistent severe hepatic failure at ICU discharge (Child-Pugh class C);
- •Patients with persistent chronic kidney disease at ICU discharge (creatinine clearance < 40 mL/min);
- •Pregnant or breastfeeding patients;
- •Patients unable to walk independently before ICU admission (those who can walk independently with assistive devices may be included);
- •Traumatic brain injury, primary cerebrovascular diseases, brain tumors, or intracranial infections;
- •Primary cognitive impairment: Alzheimer's disease, vascular dementia, hydrocephalus, etc., and other serious central nervous system diseases;
- •History of psychiatric disorders such as depression, anxiety, or schizophrenia;
- •Occurrence of respiratory or cardiac arrest;
- •Patients with known cognitive impairment, lower-limb injury, systemic neuromuscular disease, or cranial/spinal conditions that could affect outcome assessment;
- •Patients currently taking other Qi- and blood-tonifying traditional Chinese medicines or patent Chinese medicines.
研究组 & 干预措施
Experimental: Fufang E'jiao Jiang
Participants receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 days.
干预措施: Fufang E'jiao Jiang (Drug)
Placebo Comparator: Matching Placebo
Patients were given an equal-volume placebo (each vial containing compound Ejiao oral liquid [1 mL, 5%], caramel color [800 mg], and steviol glycosides [25 mg]) 20 mL orally, three times daily, for 90 consecutive days (identical to the compound Ejiao oral liquid in appearance, packaging, and taste).
干预措施: Matching Placebo (Drug)
结局指标
主要结局
6-minute walk test (6MWT)
时间窗: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital
This evaluation is based on the walking distance that patients cover in six minutes when walking as fast as possible along a straight corridor, which is a indicator for assessing the lower limb motor function.
次要结局
未报告次要终点
研究者
Tan Liang
Southwest hospital
Third Military Medical University