Hypothesis 1A: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will significantly attenuate sepsis-induced systemic organ failure as measured by overall response rate. Hypothesis 1B: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate sepsis-induced lung injury as assessed by the respiratory rate and oxygenation index. Hypothesis 1C: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate sepsis-induced lung injury as assessed by chest x-ray scale score, Chinese Medicine scale score. Hypothesis 1D: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).
Huzhangxiefei Decoction is a prescription formulated by a professional doctor of traditional Chinese medicine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days
10% Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days
ShanghaiXinhua
Shanghai, China
RECRUITINGSequential Organ Failure Assessment (SOFA) Score
SOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status
Time frame: up to 7 days
C-Reactive Protein at Study Hours 0, 96, 168 When Compared to Placebo
C-Reactive Protein at Study Hours 0, 96, 168 When Compared to Placebo
Time frame: up to 168 hours
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 96, 168 if Still Intubated in Oral Administration or Nasal Feeding of Huzhangxiefei decoction Patient Compared to Placebo
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 96, 168 if Still Intubated in Oral Administration or Nasal Feeding of Huzhangxiefei decoction Patient Compared to Placebo
Time frame: up to 168 hours
overall response rate
Overall response rate=(the number of marked response patients+the number of moderate response)/the number of all patients within group Four criteria were established as follows: 1. RR(d1)-RR(d7)≥5 breaths per minute or 12 breaths per minute≤RR(d7)≤20breaths per minute 2. OI(d7)-OI(d1)≥50mmHg 3. \[CXSS(d1)-CXSS(d7)\]/CXSS(d1)≥10% 4. CMSS(d1)-CMSS(d7)≥3 points Marked response: three or four criteria of the above are met Moderate response:two criteria of the above are met No response: none or only one criterion of the above is met RR refers to respiratory rate, breaths per minute OI refers to oxygenation index, mmHg CXSS refers to chest x-ray scale score CMSS refers to Chinese Medicine scale score
Time frame: up to 7 days
Ventilator Free Days to Day 28
Ventilator Free Days to Day 28
Time frame: Up to Day 28
ICU-free Days at Day 28
ICU-free Days at Day 28
Time frame: Up to Day 28
All Cause Mortality to Day 28
All Cause Mortality to Day 28
Time frame: Up to Day 28
Hospital-free Days at Day 60
Hospital-free Days at Day 60
Time frame: Up to Day 60
Procalcitonin at Study Hour 0, 96, 168
Procalcitonin at Study Hour 0, 96, 168
Time frame: Up to hour 168
Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 168
Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 168
Time frame: Up to hour 168
Oxygenation Score: Pressure
Oxygenation as measure by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Scores range from 100 to 300 with lower values indicating more worse outcomes
Time frame: Up to hour 168
Coagulation
Coagulation as measured by Platelets per unit of blood. Scores range from less than 20 to more than 150. Lower scores indicate worse outcomes
Time frame: Up to hour 168
Liver Function
Liver function as measured by Total Bilirubin
Time frame: Up to hour 168
Cardiovascular Function
Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.
Time frame: Up to hour 168
State of Consciousness
State of consciousness as measure by Glasgow Coma Scale which gives a score based on eye, verbal, and motor responses. Scores range from 3 to 15 with lower scores indicating worse outcome
Time frame: Up to hour 168
Renal Function
Renal function as measured by Creatinine.
Time frame: Up to hour 168
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.