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Oral Administration or Nasal Feeding of Huzhangxiefei Decoction for Treatment in Sepsis Induced Acute Lung Injury

Primary Purpose

Acute Lung Injury, Sepsis

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Huzhangxiefei Decoction

10% Huzhangxiefei Decoction

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring acute lung injury, sepsis, Chinese Traditional Medicine, Chinese Herbal Drugs, acute respiratory distress syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ShanghaiXinhuaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Huzhangxiefei Decoction

10% Huzhangxiefei Decoction

Arm Description

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 of 5 minutes after breakfast and dinner for 7 days

Outcomes

Primary Outcome Measures

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

C-Reactive Protein at Study Hours 0, 96, 168 When 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

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: RR(d1)-RR(d7)≥5 breaths per minute or 12 breaths per minute≤RR(d7)≤20breaths per minute OI(d7)-OI(d1)≥50mmHg [CXSS(d1)-CXSS(d7)]/CXSS(d1)≥10% 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

Secondary Outcome Measures

Ventilator Free Days to Day 28

ICU-free Days at Day 28

All Cause Mortality to Day 28

Hospital-free Days at Day 60

Procalcitonin at Study Hour 0, 96, 168

Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 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

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

Liver Function

Liver function as measured by Total Bilirubin

Cardiovascular Function

Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.

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

Renal Function

Renal function as measured by Creatinine.

Full Information

NCT ID

NCT04940676

First Posted

June 24, 2021

Last Updated

November 23, 2021

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04940676

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

November 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lung Injury, Sepsis

Keywords

acute lung injury, sepsis, Chinese Traditional Medicine, Chinese Herbal Drugs, acute respiratory distress syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huzhangxiefei Decoction

Arm Type

Active Comparator

Arm Description

Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days

Arm Title

10% Huzhangxiefei Decoction

Arm Type

Placebo Comparator

Arm Description

10% Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding of 5 minutes after breakfast and dinner for 7 days

Intervention Type

Drug

Intervention Name(s)

Huzhangxiefei Decoction

Intervention Description

Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days

Intervention Type

Drug

Intervention Name(s)

10% Huzhangxiefei Decoction

Intervention Description

10% Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days

Primary Outcome Measure Information:

Title

Sequential Organ Failure Assessment (SOFA) Score

Description

Time Frame

up to 7 days

Title

C-Reactive Protein at Study Hours 0, 96, 168 When Compared to Placebo

Description

C-Reactive Protein at Study Hours 0, 96, 168 When Compared to Placebo

Time Frame

up to 168 hours

Title

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

Description

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

Title

overall response rate

Description

Time Frame

up to 7 days

Secondary Outcome Measure Information:

Title

Ventilator Free Days to Day 28

Description

Ventilator Free Days to Day 28

Time Frame

Up to Day 28

Title

ICU-free Days at Day 28

Description

ICU-free Days at Day 28

Time Frame

Up to Day 28

Title

All Cause Mortality to Day 28

Description

All Cause Mortality to Day 28

Time Frame

Up to Day 28

Title

Hospital-free Days at Day 60

Description

Hospital-free Days at Day 60

Time Frame

Up to Day 60

Title

Procalcitonin at Study Hour 0, 96, 168

Description

Procalcitonin at Study Hour 0, 96, 168

Time Frame

Up to hour 168

Title

Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 168

Description

Tissue Factor Pathway Inhibitor at Study Hour 0, 96, 168

Time Frame

Up to hour 168

Title

Oxygenation Score: Pressure

Description

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

Title

Coagulation

Description

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

Title

Liver Function

Description

Liver function as measured by Total Bilirubin

Time Frame

Up to hour 168

Title

Cardiovascular Function

Description

Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.

Time Frame

Up to hour 168

Title

State of Consciousness

Description

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

Title

Renal Function

Description

Renal function as measured by Creatinine.

Time Frame

Up to hour 168

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Li Xiang, graduate

Phone

86-18555504579

1438325179@qq.com

Facility Information:

Facility Name

ShanghaiXinhua

City

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Xiang, graduate

Phone

86-18555504579

1438325179@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Oral Administration or Nasal Feeding of Huzhangxiefei Decoction for Treatment in Sepsis Induced Acute Lung Injury

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