Acute Respiratory Distress SyndromeNCT03089957
Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)
A study testing Ulinastatin in people with Acute Respiratory Distress Syndrome and Critical Illness, run by Peking University Third Hospital at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Critical Illness
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- 10 sitesChina
- Study dates
- 20 Feb 2017to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Anzhen Hospital ,Capital Medical University
Beijing, Beijing Municipality
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Chinese Pla General Hospital
Beijing, Beijing Municipality
CANGZHOU People's Hospital
Cangzhou, Hebei
The second hospital of dalian medical university
Dalian, Liaoning
The first affiliated hospital of Guangxi Medical University
Nanning, Guangxi
Peking University Shenzhen Hospital
Shenzhen, Guangdong
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Central Hospital of Zi Bo
Zibo, Shandong
About this study
Official title: Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS) A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Ulinastatin, Usual care
- Keywords
- Acute Respiratory Distress Syndrome, Critical Illness, Randomized Controlled Trial, Ulinastatin
- Medical subject headings
- Respiratory Distress Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
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.
Usual careOther
Usual care in ICU.
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin group | Experimental | 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. Receives: Drug: Ulinastatin; Other: Usual care |
| Control group | Placebo comparator | Control group will be in usual care without any intervention. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of ARDS
Measured: 3 years
Secondary outcomes (10)
The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately.
The severity of ARDS will be assessed by the Berlin Definition in mild, moderate and severe ARDs according to oxygenation.
Measured: 3 years
The number of patients who need mechanical ventilation
Measured: 3 years
Lengths of mechanical ventilation
Measured: 3 years
Lengths of ICU
Measured: 3 years
Lengths of stay
Measured: 3 years
The incidence of other organ disorders
Measured: 3 years
Mortality of 28 days
Measured: 0-28 days
Mortality of 60 days
Measured: 0-60 days
Total cost in admission
Measured: 3 years
Adverse events related to drugs.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start20 Feb 2017
- Primary completion17 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- 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, Capital Medical University
- Responsible party
- Principal investigator, Zhu Xi, Peking University Third Hospital
- Investigators
- Xi Zhu, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089957
- Sponsor's protocol ID
- 2016-0001
- Status last verified
- Jan 2024
- First submitted
- 12 Mar 2017
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be shared with other researchers in papers.
Publications
Jeong CW, Lee CS, Lee SH, Jeung HJ, Kwak SH. Urinary trypsin inhibitor attenuates liver enzyme elevation after liver resection. Korean J Anesthesiol. 2012 Aug;63(2):120-3. doi: 10.4097/kjae.2012.63.2.120. Epub 2012 Aug 14.
PubMed 22949978ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Levitt JE, Calfee CS, Goldstein BA, Vojnik R, Matthay MA. Early acute lung injury: criteria for identifying lung injury prior to the need for positive pressure ventilation*. Crit Care Med. 2013 Aug;41(8):1929-37. doi: 10.1097/CCM.0b013e31828a3d99.
PubMed 23782966Wang Z, Beach D, Su L, Zhai R, Christiani DC. A genome-wide expression analysis in blood identifies pre-elafin as a biomarker in ARDS. Am J Respir Cell Mol Biol. 2008 Jun;38(6):724-32. doi: 10.1165/rcmb.2007-0354OC. Epub 2008 Jan 18.
PubMed 18203972Wang Z, Tao L, Yan Y, Zhu X. Rationale and design of a prospective, multicentre, randomised, conventional treatment-controlled, parallel-group trial to evaluate the efficacy and safety of ulinastatin in preventing acute respiratory distress syndrome in high-risk patients. BMJ Open. 2019 Mar 7;9(3):e025523. doi: 10.1136/bmjopen-2018-025523.
PubMed 30850411
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS) A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03089957
- Acronym / sponsor ID
- 2016-0001
- Keywords
- Acute Respiratory Distress Syndrome, Critical Illness, Randomized Controlled Trial, Ulinastatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- 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, Capital Medical University
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin group | Experimental | Drug: Ulinastatin, Other: Usual care200,000 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. |
| Control group | Placebo comparator | Other: Usual careControl group will be in usual care without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulinastatin200,000 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 group |
| Usual careUsual care in ICU. | Other | Control group, Ulinastatin group |
Primary outcome
The incidence of ARDS
Time frame: 3 years
10 secondary outcomes
The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately.
Time frame: 3 years
The number of patients who need mechanical ventilation
Time frame: 3 years
Lengths of mechanical ventilation
Time frame: 3 years
Lengths of ICU
Time frame: 3 years
Lengths of stay
Time frame: 3 years
The incidence of other organ disorders
Time frame: 3 years
Mortality of 28 days
Time frame: 0-28 days
Mortality of 60 days
Time frame: 0-60 days
Total cost in admission
Time frame: 3 years
Adverse events related to drugs.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 22949978Jeong CW, Lee CS, Lee SH, Jeung HJ, Kwak SH. Urinary trypsin inhibitor attenuates liver enzyme elevation after liver resection. Korean J Anesthesiol. 2012 Aug;63(2):120-3. doi: 10.4097/kjae.2012.63.2.120. Epub 2012 Aug 14.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 23782966Levitt JE, Calfee CS, Goldstein BA, Vojnik R, Matthay MA. Early acute lung injury: criteria for identifying lung injury prior to the need for positive pressure ventilation*. Crit Care Med. 2013 Aug;41(8):1929-37. doi: 10.1097/CCM.0b013e31828a3d99.
- Background: PubMed 18203972Wang Z, Beach D, Su L, Zhai R, Christiani DC. A genome-wide expression analysis in blood identifies pre-elafin as a biomarker in ARDS. Am J Respir Cell Mol Biol. 2008 Jun;38(6):724-32. doi: 10.1165/rcmb.2007-0354OC. Epub 2008 Jan 18.
- Derived from this study: PubMed 30850411Wang Z, Tao L, Yan Y, Zhu X. Rationale and design of a prospective, multicentre, randomised, conventional treatment-controlled, parallel-group trial to evaluate the efficacy and safety of ulinastatin in preventing acute respiratory distress syndrome in high-risk patients. BMJ Open. 2019 Mar 7;9(3):e025523. doi: 10.1136/bmjopen-2018-025523.
- Individual participant dataSharing planned: Undecided. All data will be shared with other researchers in papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Zhu, M.D. principal investigator
Peking University Third Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin in people with Acute Respiratory Distress Syndrome and Critical Illness, run by Peking University Third Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of ARDS (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089957, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.