Evaluation of Efficacy of YiQiFuMai Injection as an Adjunctive Treatment for Sepsis: a Single Center Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Length of stay in ICU
研究概览
简要总结
This is a prospective single center pilot randomized controlled study to assess the efficacy and safety of YiQiFuMai injection (YQFM), a widely used Chinese medicine, as an adjunctive treatment for sepsis.
详细描述
Sepsis is a major clinical challenge with high mortality and morbidity worldwide. Sepsis is characterized by the dysregulated host response to an infection followed by organ dysfunction. Early sepsis mortality has diminished with advances in intensive care management and goal-directed interventions, only to surge after "recovery" from acute events, which prompts a search for sepsis-induced alterations in immune function. When suffered from sepsis, patients may have evidence of hyper-inflammation and immunosuppression. There are no high-quality evidence examining the effect of intravenous (IV) immunoglobulins or other immune modulators on the outcomes of patients with sepsis or septic shock. YiQiFuMai Injection (YQFM) is a redeveloped preparation based on the traditional Chinese medicine formula Sheng-Mai-San, which is widely used in clinical practice in China, mainly for the microcirculatory disturbance-related diseases. YQFM is proved to be effective for treating sepsis (unpublished data). And several researches reveal that YQFM attenuates acute respiratory distress syndrome and lipopolysaccharide-induced microvascular disturbance in vitro.
The purpose of this study is to explore the adjunctive treatment effect of YQFM to prognosis, immune dysfunction and organ dysfunction of sepsis.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sepsis defined by Sepsis-3 definition
- •Adult patients between the ages of 18 and
- •Informed consent is provided by patients or obtained by family member if patient is incapacitated.
排除标准
- •Known severe allergic reaction to drugs including but not limited to YQFM.
- •Pregnant patients or those who may be pregnant
- •Patients with severe intracranial diseases (intracranial artery stenosis, intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, subjects after intracranial surgery)
- •Patients with extremely severe brain injury, after cardiopulmonary resuscitation, advanced malignant tumor, combined with serious primary diseases such as liver, lung, kidney and hematopoietic system, and poor prognosis;
- •Autoimmune diseases, immune deficiency diseases, continuous use of immunosuppressants within the last 6 months, or organ transplants;
- •Major surgery or trauma within the last 2 weeks;
- •Participated in other clinical trials or took similar drugs within 1 month;
- •The investigator considered that the subjects had poor compliance or other clinical, social, or family factors that were inappropriate for inclusion in the study.
研究组 & 干预措施
YQFM group
YQFM 5.2g in 0.9% Normal Saline 250ml IV, about 40 drops per min, once a day.
干预措施: YiQiFuMai (Drug)
Placebo group
0.9% Normal Saline 250ml IV, about 40 drops per min.
干预措施: 0.9% Normal Saline 250ml (Drug)
结局指标
主要结局
Length of stay in ICU
时间窗: up to 28 days after randomization
Absolute lymphocyte count in the routine blood test (*10^9g/L)
时间窗: Change from baseline at 14 days after randomization
Mortality in ICU and several time points
时间窗: In 14 days after randomization
Death from all causes at ICU discharge, 7 days, and 14 days after randomization
The secondary infection rate in 28 days.
时间窗: In 28 days after randomization
All-cause Mortality [28 days after randomization]
时间窗: In 28 days after randomization
Death from all causes at 28-days
Concentration of T cells and B cells
时间窗: Change from baseline at 14 days after randomization
CD3+CD4-CD8-, CD3+CD4+CD8-, CD3+CD4-CD8+, CD3+CD4+CD8+, CD3+CD19-, CD3-CD19+, CD3+(CD16+CD56)+, CD3-(CD16+CD56)+ ,CD4+CD25+,CD4+CD25+CD127- (cells/uL)
Concentration of inflammatory cytokines
时间窗: Change from baseline at 14 days after randomization
interleukin (IL) 1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-17, interferon (IFN) α, IFN-γ, and Tumor nuclear factor (TNF)-α. (pg/mL);
Concentration of Procalcitonin
时间窗: Change from baseline at 14 days after randomization
Length of stay in hospital
时间窗: up to 28 days after randomization
次要结局
- Concentration of IgM, IgG, IgE (g/L) (blood)(change from baseline at 14 days after randomization)
- Total amount of fluid resuscitation (mL) in ICU(up to 28 days after randomization)
- SOFA score(Change from baseline at 14 days after randomization)
- APACHEII(change from baseline at 7 days after randomization)
- Duration of fluid resuscitation in ICU(up to 28 days after randomization)
- Duration of mechanical ventilation (MV) in ICU(up to 28 days after randomization)
- Duration of continual renal replacement therapy (CRRT) in ICU(up to 28 days after randomization)
- Duration of vasopressor drugs in ICU(up to 28 days after randomization)
- Concentration of complement in serum (C3 and C4) (g/L)(change from baseline at 14 days after randomization)
- Self-Rating Anxiety Scale (SAS) score(change from baseline at 28 days after randomization)
- Self-Rating Depression Scale (SDS) score(change from Day 7 at 28 days after randomization)
- Barthel score(change from baseline at 28 days after randomization)
- The mean artery pressure (MBP)(change from baseline at 7 days after randomization)
- The worst heart rate(change from baseline at 7 days after randomization)
- Concentration of serum lactate(change from baseline at 14 days after randomization)
- The rate of lactate clearance(change from baseline at 14 days after randomization)
- The volume of urine output(change from baseline at 14 days after randomization)
研究者
Anlu Wang, MD
Prof.
Xiyuan Hospital of China Academy of Chinese Medical Sciences