Clinical Collaboration Project of Integrated Traditional Chinese and Western Medicine for Major and Intractable Diseases - A Multicenter, Randomized Controlled Trial of Xuanbai Shengmai Decoction in the Treatment of Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 主要终点
- 28-day mortality
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a common clinical syndrome in the ICU characterized by extremely high mortality and complex pathogenesis.At present, research on individualized treatment, phenotypic differences, and therapeutic efficacy in ARDS has become a hotspot.As characterized by syndrome differentiation, traditional Chinese medicine (TCM) treatment emphasizes interindividual heterogeneity and personalized management, which is expected to serve as a breakthrough in multi-target immune regulation for ARDS. The primary objective of the study is to investigate the effect of Xuanbai Shengmai Decoction on the prognosis of patients with ARDS in a prospective randomized controlled trial. The secondary objective is to evaluate the safety of Xuanbai Shengmai Decoction in the treatment of patients with ARDS.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met the diagnostic criteria for ARDS according to the 2023 updated global definition.
- •Within 48 hours of meeting the diagnostic criteria.
- •Aged ≥ 18 years and ≤ 85 years.
排除标准
- •Did not meet the diagnostic criteria.
- •Pregnant or lactating women.
- •Patients with gastrointestinal dysfunction (including gastrointestinal bleeding, severe intra-abdominal hypertension, severe intestinal obstruction, etc.), resulting in the inability to administer medication via nasogastric/nasoenteric tube or orally within 48 hours after enrollment.
- •SOFA score >
- •Hypersensitivity to the study drugs.
- •Withdrawal of treatment.
研究组 & 干预措施
Control Group
Patients in the control group will receive standard comprehensive Western medical treatment.
Treatment Group
Patients in the treatment group will receive Xuanbai Shengmai Decoction via oral administration or nasogastric feeding on the basis of standard comprehensive Western medical treatment. The decoction will be administered within 24 hours after enrollment, one dose per day divided into two administrations, for a total treatment duration of 7 days.
干预措施: Xuanbai Shengmai Decoction (Drug)
结局指标
主要结局
28-day mortality
时间窗: On day 28 of treatment
Mortality was calculated on day 28 of treatment.
次要结局
- Clinical scoring indicator: LIS(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Inflammatory indicator: Interleukin-6 (IL-6,pg/mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Lung injury indicator:Oxygenation index (PaO₂/FiO₂ ratio)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Ventilator parameter: Tidal volume (VT, mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Duration of mechanical ventilation(within 28 days)
- Length of ICU stay(within 28 days)
- Multiplex detection:Pathogen Load by Multiplex PCR(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Clinical scoring indicator:Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) score(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Clinical scoring indicators: Sequential Organ Failure Assessment (SOFA) score(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Lung injury indicator:Static lung compliance( mL/cmH₂O)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Lung injury indicator:Serum soluble receptor for advanced glycation end products (sRAGE,pg/mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Lung injury indicator:Electrical impedance tomography (EIT) parameters of lung ventilation(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Ventilator parameter:Pressure support (PS, cmH₂O)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Ventilator parameter:Positive end-expiratory pressure (PEEP, cmH₂O)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Ventilator parameter:Fraction of inspired oxygen (FiO₂, %)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Pulmonary vascular permeability indicator: Lung ultrasound B-line score(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Inflammatory indicator:Tumor necrosis factor-α (TNF-α,pg/mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Inflammatory indicator:C-reactive protein (CRP,mg/L)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Inflammatory indicator:Procalcitonin (PCT,ng/mL)(Before treatment,on day 3 of treatment,on day 7 of treatment)
- Microecology:Gut Microbiota Alpha Diversity (Shannon Index)(Baseline, Day 3, Day 7 of treatment)
- Metabolomics analysis:Serum Target Metabolite Concentration(Baseline, Day 3, Day 7 of treatment)
研究者
Ling Liu
Professor
Southeast University, China