The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
1 other identifier
interventional
60
1 country
11
Brief Summary
Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2016
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 20, 2018
April 1, 2018
3.1 years
July 21, 2016
April 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
Day 1 to Day 90
Secondary Outcomes (9)
Changes of PaO2/FiO2 ratio
Day 0 and Day 1 to within 24h after the last treatment
Days alive and off ventilator
Day 1 to Day 28
Days in the ICU
Day 1 to Day 14
Changes of pulmonary compliance
Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Rate of new organ failure
Day 1 to Day 90
- +4 more secondary outcomes
Study Arms (4)
Cohort 1
EXPERIMENTALCohort 1- Ulinastatin 4.8 million units per day
Cohort 2
EXPERIMENTALCohort 2- Ulinastatin 2.4 million units per day
Cohort 3
EXPERIMENTALCohort 3- Ulinastatin 1.2 million units per day
control group
PLACEBO COMPARATORPlacebo
Interventions
Patients will receive the study drugs for 7 to 14 days
Eligibility Criteria
You may qualify if:
- Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
- Male or Female patients ≥18 years of age;
- ARDS defined with using 2012 Berlin Criteria;
- ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg \< PaO2/FiO2 \< 250mmhg with CPAP/PEEP≥5 cmH2O;
You may not qualify if:
- Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
- Patients with artificial organs replacement therapy for liver or kidney；
- Glasgow Coma Scale (GCS)≤8；
- Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
- ARDS caused by burning, drowning, poisoning;
- Presence of severe chronic liver diseases (Child-Pugh score 12-15)，or severe chronic respiratory disease with a PaCO2 \> 50 mmHg or the use of home oxygen;
- Neutrophils\<1.5×10\^9/L
- Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent (within 7days or anytime during present hospitalization) cardiopulmonary arrest;
- Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs;
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol;
- Lung transplant patients;
- Patients with malignancy, expected to live no longer than 6 months;
- Pregnant or breast-feeding;
- Patients who have participated in any clinical study within 3 months prior to the screening;
- Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Huadong Hospital,Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Sixth People's Hospital
Shanghai, Shanghia, 200233, China
West China Hospital,Sichuan Unversity
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310030, China
Lishui City People's Hospital
Lishui, Zhejiang, 323000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yimin Li, Doctor
First Affiliated Hospital of Guangzhou Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2016
First Posted
September 9, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
April 20, 2018
Record last verified: 2018-04