Improvement of Organ Function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, Pilot Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 96-hour Sequential Organ Failure Assessment (SOFA) score
研究概览
简要总结
In this single-center, randomized, single-blind, placebo-controlled pilot clinical trial. The effect of apigenin on the improvement of organ function will be investigated in elderly patients with sepsis. Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital to identify patients with sepsis based on including and excluding criteria and obtain informed consent and randomize them into groups. The treatment group will be given apigenin tablets 50mg ground with 5ml of sterilized water for intra-gastric tube injection; the control group will be given an equal volume of sterilized water for intra-gastric tube injection. The changes in SOFA score and other clinically meaningful outcomes in 4 days will be collected.
详细描述
Investigational drug: Apigenin Study title: Improvement of Organ function by Apigenin in Elderly Patients With Sepsis: A Single-center, Single-blind, Randomized, Placebo-controlled, pilot Clinical Trial Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University Study subjects: Elderly septic/septic shock patients who meet the diagnostic criteria of the 2016 International Sepsis Guidelines.
Study objectives: The objective of the study is to determine whether apigenin, compared to placebo, improves organ dysfunction scores (SOFA scores) in elderly septic patients.
Study design: A single-center, single-blind, randomized, placebo-controlled pilot Clinical Trial.
Method: Apigenin group: Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 days or until ICU discharge. Placebo control group: Gastric tube injection of 5 ml of sterilized water for injection + conventional standardized treatment, for 4 days or ICU discharge.
Course: 4 days Sample size: 20 The number of study center: 1
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
- Single (Participant)
盲法说明
Single(Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥65 years;
- •meeting the diagnostic criteria of the 2016 International Sepsis Guidelines;
- •subjects who voluntarily participated in this study and signed an informed consent form.
排除标准
- •patients who are allergic to the study products;
- •patients who are unable to feed via gastrointestinal nutrition tube.
研究组 & 干预措施
apigenin
Intragastric tube injection of ground apigenin tablet 50 mg with 5 ml of sterilized water + conventional standardized treatment, for 4 consecutive days.
干预措施: apigenin (Other)
结局指标
主要结局
96-hour Sequential Organ Failure Assessment (SOFA) score
时间窗: The outcome will be assessed at the 0,1,2,3,4 day after enrollment
The SOFA score is the Sequential Organ Failure Score, which is used to assess a patient's prognosis by determining the degree of impairment of major organ function. The score is divided into 6 sections: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal, and ranges from 0 to 4, with higher SOFA scores associated with a higher incidence of poor prognosis.
次要结局
- Indicators of infection(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- lung function(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- kidney function(2)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- fluid balance(The outcome will be assessed at the 1,2,3,4 day after enrollment)
- liver function(3)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- The duration of CRRT(The outcome will be assessed at the 28 day after enrollment)
- liver function(2)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- kidney function(1)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- The level of lactate(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- The Duration of use of mechanical ventilation (MV)(The outcome will be assessed at the 28 day after enrollment)
- inflammatory response(1)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- inflammatory response(2)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- Duration of use of vasoactive drugs(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- liver function(1)(The outcome will be assessed at the 0,1,2,3,4 day after enrollment)
- Daily urine output(The outcome will be assessed at the 1,2,3,4 day after enrollment)
- The length of ICU stay(The outcome will be assessed at the 28 day after enrollment)
研究者
Liu Zhanguo
Director of the department of critical care medicine, Principal Investigator
Zhujiang Hospital