Clinical trial NCT04940676: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction for Treatment in Sepsis Induced Acute Lung Injury
Official title: Oral Administration or Nasal Feeding of Huzhangxiefei Decoction for Treatment in Sepsis Induced Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lung Injury
Sepsis
Keywords: acute lung injury
sepsis
Chinese Traditional Medicine
Chinese Herbal Drugs
acute respiratory distress syndrome
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Huzhangxiefei Decoction is a prescription formulated by a professional doctor of traditional Chinese medicine

Eligibility criteria: Inclusion Criteria:

* Patients must have suspected or proven infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).

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:

* inability to obtain consent;
* age \< 18 years;
* pregnancy or breast feeding;
* moribund patient not expected to survive 24 hours;
* for patients with chronic liver insufficiency, renal insufficiency, blood system disease, etc., it is impossible to judge that the organ insufficiency occurred after this infection

Primary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: up to 7 days
measure: C-Reactive Protein at Study Hours 0, 96, 168 When Compared to Placebo
timeFrame: up to 168 hours
measure: 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
timeFrame: up to 168 hours
measure: overall response rate
timeFrame: up to 7 days
Secondary outcomes:
measure: Ventilator Free Days to Day 28
timeFrame: Up to Day 28
measure: ICU-free Days at Day 28
timeFrame: Up to Day 28
measure: All Cause Mortality to Day 28
timeFrame: Up to Day 28
measure: Hospital-free Days at Day 60
timeFrame: Up to Day 60
measure: Procalcitonin at Study Hour 0, 96, 168
timeFrame: Up to hour 168
measure: Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 168
timeFrame: Up to hour 168
measure: Oxygenation Score: Pressure
timeFrame: Up to hour 168
measure: Coagulation
timeFrame: Up to hour 168
measure: Liver Function
timeFrame: Up to hour 168
measure: Cardiovascular Function
timeFrame: Up to hour 168
measure: State of Consciousness
timeFrame: Up to hour 168
measure: Renal Function
timeFrame: Up to hour 168
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShanghaiXinhua
Study officials:
References: