A Phase 2 interventional study of Huzhangxiefei Decoction and 10% Huzhangxiefei Decoction in Acute Lung Injury and Sepsis, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 58 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system).
The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection): Sepsis associated hypotension (systolic blood pressure (SBP) \< 90 mm Hg or an SBP decrease > 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin); Arterial hypoxemia (PaO2/FiO2 \< 300) or supplemental O2 > 6LPM; Lactate > upper limits of normal laboratory results; Urine output \< 0.5 ml/kg/hour for > two hours despite adequate fluid resuscitation; Platelet count \< 100,000 per mcL; Coagulopathy (INR > 1.5); Bilirubin > 2 mg/dL; Glasgow Coma Scale \< 11 or a positive CAM ICU score.
ARDS characterized by all the following criteria Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules) Respiratory failure not explained by heart failure or volume overload Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg Minimum PEEP of 5 cmH2O (may be delivered noninvasively with CPAP to diagnose mild ARDS
Exclusion Criteria:
Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days
Drug: Huzhangxiefei Decoction
10% Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding of 5 minutes after breakfast and dinner for 7 days
Drug: 10% Huzhangxiefei Decoction
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
Sequential 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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine