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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
308
Patients in the treatment group will receive Xuanbai Shengmai Decoction orally or via nasogastric gavage on the basis of standard comprehensive Western medical treatment. The decoction will be administered within 24 hours after enrollment, one dose per day in two divided administrations, for a total of 7 days.
28-day mortality
Mortality was calculated on day 28 of treatment.
Time frame: On day 28 of treatment
Clinical scoring indicator: LIS
Clinical scores were assessed before treatment, on day 3 of treatment, and on day 7 of treatment.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator: Interleukin-6 (IL-6,pg/mL)
Serum IL-6 levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL)
The concentration of angiopoietin-2 in peripheral blood (pg/mL) will be measured at baseline (pre-treatment), Day 3, and Day 7 of treatment, as a biomarker of pulmonary vascular permeability.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Lung injury indicator:Oxygenation index (PaO₂/FiO₂ ratio)
Arterial blood gas samples will be collected at baseline (pre-treatment), Day 3, and Day 7 of treatment to determine the ratio of arterial partial pressure of oxygen (PaO₂) to the fraction of inspired oxygen (FiO₂), which will be used to assess the patient's oxygenation status.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter: Tidal volume (VT, mL)
The ventilator-set tidal volume (in mL) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Duration of mechanical ventilation
Duration of mechanical ventilation within 28 days
Time frame: within 28 days
Length of ICU stay
Time of staying in ICU within 28 days
Time frame: within 28 days
Multiplex detection:Pathogen Load by Multiplex PCR
Throat swabs, fecal samples (10g), and peripheral blood (3mL) will be collected at baseline, day 3, and day 7 of treatment. Multiplex PCR will be performed to detect the nucleic acid load of target pathogens, with the unit of copies/mL, to evaluate changes in infection burden.
Time frame: 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
Assessed using the full APACHE Ⅱ scale at baseline (pre-treatment), Day 3, and Day 7 of treatment. The scale consists of three components: acute physiology score, age score, and chronic health evaluation score, with a total score ranging from 0 to 71. Higher scores indicate greater severity of illness and higher risk of mortality.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Clinical scoring indicators: Sequential Organ Failure Assessment (SOFA) score
Assessed using the full Sequential Organ Failure Assessment scale at baseline (pre-treatment), day 3, and day 7 of treatment. The score evaluates the function of six organ systems: respiratory, coagulation, hepatic, cardiovascular, neurological, and renal, with a total range of 0-24. Higher scores indicate more severe organ dysfunction and a worse prognosis.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Lung injury indicator:Static lung compliance( mL/cmH₂O)
Static lung compliance ( mL/cmH₂O) will be calculated via the ventilator monitoring platform under constant tidal volume and plateau pressure conditions at baseline (pre-treatment), Day 3, and Day 7 of treatment, to assess respiratory mechanics function.
Time frame: 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)
Peripheral blood samples will be collected at baseline (pre-treatment), Day 3, and Day 7 of treatment to measure serum sRAGE levels (pg/mL), which serves as a biomarker of pulmonary epithelial injury.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Lung injury indicator:Electrical impedance tomography (EIT) parameters of lung ventilation
Lung ventilation distribution will be monitored by EIT at baseline (pre-treatment), Day 3, and Day 7 of treatment to assess lung injury-related indicators including lung collapse, overdistension, and ventilation inhomogeneity.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Pressure support (PS, cmH₂O)
The pressure support level provided by the ventilator (in cmH₂O) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Positive end-expiratory pressure (PEEP, cmH₂O)
The positive airway pressure maintained at the end of expiration (in cmH₂O) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Ventilator parameter:Fraction of inspired oxygen (FiO₂, %)
The fraction of inspired oxygen set on the ventilator (in %) will be recorded directly from the ventilator interface at baseline (pre-treatment), Day 3, and Day 7 of treatment.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Pulmonary vascular permeability indicator: Lung ultrasound B-line score
The number and distribution of B-lines are assessed and scored by lung ultrasound at baseline (pre-treatment), Day 3, and Day 7 of treatment. A higher number and more diffuse distribution of B-lines indicate more severe pulmonary edema. This score is used to evaluate pulmonary vascular permeability and the severity of pulmonary edema.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:Tumor necrosis factor-α (TNF-α,pg/mL)
Serum TNF-α levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:C-reactive protein (CRP,mg/L)
Serum CRP levels (mg/L) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Inflammatory indicator:Procalcitonin (PCT,ng/mL)
Serum PCT levels (ng/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response.
Time frame: Before treatment,on day 3 of treatment,on day 7 of treatment
Microecology:Gut Microbiota Alpha Diversity (Shannon Index)
Fecal samples (10g) will be collected at baseline, day 3, and day 7 of treatment. 16S rRNA high-throughput sequencing will be performed to analyze gut microbiota alpha diversity (Shannon index, unitless) to evaluate changes in intestinal microecological homeostasis.
Time frame: Baseline, Day 3, Day 7 of treatment
Metabolomics analysis:Serum Target Metabolite Concentration
Peripheral blood (3mL) will be collected at baseline, day 3, and day 7 of treatment. Untargeted metabolomics will be performed to detect the concentration of target serum metabolites, with the unit of μmol/L, to evaluate changes in the body's metabolic status.
Time frame: Baseline, Day 3, Day 7 of treatment
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