Acute Respiratory Distress Syndrome (ARDS)
Conditions
Keywords
Acute Respiratory Distress Syndrome (ARDS), Traditional Chinese Medicine, Xuanbai Shengmai Decoction
Brief summary
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.
Interventions
DRUGXuanbai Shengmai Decoction
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.
Sponsors
Southeast University, China
Beijing Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Guangzhou Medical University
Jiangsu Province Hospital of Traditional Chinese Medicine
Subei People's Hospital of Jiangsu Province
Wuhan Hospital of Traditional Chinese Medicine
Shenzhen Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Met the diagnostic criteria for ARDS according to the 2023 updated global definition. 2. Within 48 hours of meeting the diagnostic criteria. 3. Aged ≥ 18 years and ≤ 85 years.
Exclusion criteria
1. Did not meet the diagnostic criteria. 2. Pregnant or lactating women. 3. 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. 4. SOFA score \> 13. 5. Hypersensitivity to the study drugs. 6. Withdrawal of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | On day 28 of treatment | Mortality was calculated on day 28 of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical scoring indicator: LIS | Before treatment,on day 3 of treatment,on day 7 of treatment | Clinical scores were assessed before treatment, on day 3 of treatment, and 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 | Serum IL-6 levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response. |
| Pulmonary vascular permeability indicator: Serum angiopoietin-2 (Ang-2,pg/mL) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Lung injury indicator:Oxygenation index (PaO₂/FiO₂ ratio) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Ventilator parameter: Tidal volume (VT, mL) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Duration of mechanical ventilation | within 28 days | Duration of mechanical ventilation within 28 days |
| Length of ICU stay | within 28 days | Time of staying in ICU within 28 days |
| Multiplex detection:Pathogen Load by Multiplex PCR | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| 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 | 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. |
| Clinical scoring indicators: Sequential Organ Failure Assessment (SOFA) score | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Lung injury indicator:Static lung compliance( mL/cmH₂O) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| 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 | 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. |
| Lung injury indicator:Electrical impedance tomography (EIT) parameters of lung ventilation | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Ventilator parameter:Pressure support (PS, cmH₂O) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Ventilator parameter:Positive end-expiratory pressure (PEEP, cmH₂O) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Ventilator parameter:Fraction of inspired oxygen (FiO₂, %) | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Pulmonary vascular permeability indicator: Lung ultrasound B-line score | Before treatment,on day 3 of treatment,on day 7 of treatment | 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. |
| Inflammatory indicator:Tumor necrosis factor-α (TNF-α,pg/mL) | Before treatment,on day 3 of treatment,on day 7 of treatment | Serum TNF-α levels (pg/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response. |
| Inflammatory indicator:C-reactive protein (CRP,mg/L) | Before treatment,on day 3 of treatment,on day 7 of treatment | Serum CRP levels (mg/L) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response. |
| Inflammatory indicator:Procalcitonin (PCT,ng/mL) | Before treatment,on day 3 of treatment,on day 7 of treatment | Serum PCT levels (ng/mL) are measured at baseline, Day 3, and Day 7 as a marker of systemic inflammatory response. |
| Microecology:Gut Microbiota Alpha Diversity (Shannon Index) | Baseline, Day 3, Day 7 of treatment | 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. |
| Metabolomics analysis:Serum Target Metabolite Concentration | Baseline, Day 3, Day 7 of treatment | 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. |
Contacts
CONTACTAiran Liu, PhD
Outcome results
None listed