Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089957
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : September 24, 2018
Sponsor:
Collaborators:
Chinese PLA General Hospital
The First Affiliated Hospital of Zhengzhou University
Peking University Shenzhen Hospital
Central Hospital of Zi Bo
Beijing Anzhen Hospital
The Second Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Guangxi Medical University
Beijing Shijitan Hospital Affiliated to Capital Medical University
Information provided by (Responsible Party):
Xi Zhu, Peking University Third Hospital

Brief Summary:

Since strategies were applied in intensive care medicine, including low tidal volume ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has been decreased recent years. However, the mortality of severe ARDS is still higher to 45%. Few medications did were indicated to be effective in working on development of ARDS. Different with other disease, ARDS were difficult to prevent in its later stage like a domino effect. The medication interventions are all used after ARDS was developed, including ulinastatin. The investigators hypothesized that the key point in failure of medication therapy is the delay timing of medication intervention. If given the preventive strategy, such as ulinastatin, the incidence or the severity of ARDS might be decreased. Therefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS.

This is a multi-center, randomized, double blinded, placebo controlled study.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Critical Illness Drug: Ulinastatin Other: Usual care Not Applicable

Detailed Description:

Since strategies were applied in intensive care medicine, including low tidal volume ventilation, fluid resuscitation, use of antibiotics, restrictive transfusion strategy and bundle of ventilator therapy, the incidence of Acute Respiratory Distress Syndrome (ARDS) has been decreased recent years. However, the mortality of severe ARDS is still higher to 45%. Few medications did were indicated to be effective in working on development of ARDS. Different with other disease, ARDS were difficult to prevent in its later stage like a domino effect. The medication interventions are all used after ARDS was developed, including ulinastatin. The investigators hypothesized that the key point in failure of medication therapy is the delay timing of medication intervention. If given the preventive strategy, such as ulinastatin, the incidence or the severity of ARDS might be decreased.

Ulinastatin is a urinary trypsin inhibitor (UTI) that inhibits various inflammatory proteases has been widely used in China, Japan, and Korea for the treatment of patients with inflammatory disorders, postoperative organs protection, shock, and pancreatitis.

Therefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS.

This is a multi-center, randomized, double blinded, placebo controlled study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS) A Randomized Controlled Trial
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Ulinastatin group
200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.
Drug: Ulinastatin
200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.

Other: Usual care
Usual care in ICU.

Placebo Comparator: Control group
Control group will be in usual care without any intervention.
Other: Usual care
Usual care in ICU.




Primary Outcome Measures :
  1. The incidence of ARDS [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately. [ Time Frame: 3 years ]
    The severity of ARDS will be assessed by the Berlin Definition in mild, moderate and severe ARDs according to oxygenation.

  2. The number of patients who need mechanical ventilation [ Time Frame: 3 years ]
  3. Lengths of mechanical ventilation [ Time Frame: 3 years ]
  4. Lengths of ICU [ Time Frame: 3 years ]
  5. Lengths of stay [ Time Frame: 3 years ]
  6. The incidence of other organ disorders [ Time Frame: 3 years ]
  7. Mortality of 28 days [ Time Frame: 0-28 days ]
  8. Mortality of 60 days [ Time Frame: 0-60 days ]
  9. Total cost in admission [ Time Frame: 3 years ]
  10. Adverse events related to drugs. [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: 3 years ]
    Including white blood cell decrease, eosinophils increase, nausea, vomiting, diarrhoea, liver enzymes increase, allergy, adverse events in injection sites and etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should be more than 18 years old
  • Patients are expected to living within 72 hours of ICU admission
  • Patients' Lung Injury Prediction Score (LIPS) more than 4 and got at least 1 risk factors as below: bacteremia, sepsis or sepsis shock, pneumonia, multiple fractures, pulmonary contusion, aspiration, multiple blood transfusion, severe acute pancreatitis.

Exclusion Criteria: Patients will be excluded when they are

  • diagnosed as ARDS
  • without written informed consent
  • with HIV infection
  • with other immunologic deficiency (leukaemia, immune deficiency syndrome, etc)
  • with organ transplantation or bone marrow transplantation
  • with chronic pulmonary disease (except for Chronic Obstructive Pulmonary Disease (COPD) or asthma)
  • with angitis
  • with neutropenia (except for secondary to sepsis)
  • using granulocyte-macrophage colony-stimulating factor or granulocyte colony-stimulating factor
  • using asprin or clopidogrel
  • using glucocorticoid
  • withdrawing treatment
  • treated by Xuebijing, thymosin, or intravenous immunoglobulin 1 month before enrollment
  • enrolled in other clinical trials 3 months before enrollment
  • being pregnancy
  • being lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089957


Contacts
Layout table for location contacts
Contact: Xi Zhu, M.D. xizhuccm@163.com

Locations
Layout table for location information
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Xi Zhu, M.D.       xizhuccm@163.com   
Beijing Anzhen Hospital ,Capital Medical University Recruiting
Beijing, Beijing, China
Beijing Shijitan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China
Chinese Pla General Hospital Recruiting
Beijing, Beijing, China
Contact: Feihu Zhou, MD,PHD         
China, Guangdong
Peking University Shenzhen Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Weixing Zhang, MD,MS         
China, Guangxi
The first affiliated hospital of Guangxi Medical University Recruiting
Nanning, Guangxi, China
China, Hebei
CANGZHOU People's Hospital Recruiting
Cangzhou, Hebei, China
Contact: Wensheng Wang, MD,MS         
China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China
Contact: Tongwen Sun, MD,PHD         
China, Liaoning
The second hospital of dalian medical university Recruiting
Dalian, Liaoning, China
China, Shandong
Central Hospital of Zi Bo Recruiting
Zibo, Shandong, China
Contact: Shifu Wang, MD,MS         
Sponsors and Collaborators
Peking University Third Hospital
Chinese PLA General Hospital
The First Affiliated Hospital of Zhengzhou University
Peking University Shenzhen Hospital
Central Hospital of Zi Bo
Beijing Anzhen Hospital
The Second Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Guangxi Medical University
Beijing Shijitan Hospital Affiliated to Capital Medical University
Investigators
Layout table for investigator information
Principal Investigator: Xi Zhu, M.D. Peking University Third Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Xi Zhu, M.D. Chief physician, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03089957     History of Changes
Other Study ID Numbers: 2016-0001
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data will be shared with other researchers in papers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xi Zhu, Peking University Third Hospital:
Acute Respiratory Distress Syndrome
Critical Illness
Randomized Controlled Trial
Ulinastatin
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Critical Illness
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Disease Attributes
Lung Injury
Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action