Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03089957
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2017-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028665', 'term': 'urinastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2017-03-12', 'studyFirstSubmitQcDate': '2017-03-19', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '3 years', 'description': 'Including white blood cell decrease, eosinophils increase, nausea, vomiting, diarrhoea, liver enzymes increase, allergy, adverse events in injection sites and etc.'}], 'primaryOutcomes': [{'measure': 'The incidence of ARDS', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'The numbers of ARDS patients who meet the criteria for mild, moderate, and severe using the Berlin Definition, separately.', 'timeFrame': '3 years', 'description': 'The severity of ARDS will be assessed by the Berlin Definition in mild, moderate and severe ARDs according to oxygenation.'}, {'measure': 'The number of patients who need mechanical ventilation', 'timeFrame': '3 years'}, {'measure': 'Lengths of mechanical ventilation', 'timeFrame': '3 years'}, {'measure': 'Lengths of ICU', 'timeFrame': '3 years'}, {'measure': 'Lengths of stay', 'timeFrame': '3 years'}, {'measure': 'The incidence of other organ disorders', 'timeFrame': '3 years'}, {'measure': 'Mortality of 28 days', 'timeFrame': '0-28 days'}, {'measure': 'Mortality of 60 days', 'timeFrame': '0-60 days'}, {'measure': 'Total cost in admission', 'timeFrame': '3 years'}, {'measure': 'Adverse events related to drugs.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory Distress Syndrome', 'Critical Illness', 'Randomized Controlled Trial', 'Ulinastatin'], 'conditions': ['Acute Respiratory Distress Syndrome', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '22949978', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22797452', 'type': 'BACKGROUND', 'citation': 'ARDS 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.'}, {'pmid': '23782966', 'type': 'BACKGROUND', 'citation': 'Levitt 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.'}, {'pmid': '18203972', 'type': 'BACKGROUND', 'citation': 'Wang 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.'}, {'pmid': '30850411', 'type': 'DERIVED', 'citation': 'Wang 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis is a multi-center, randomized, double blinded, placebo controlled study.', 'detailedDescription': '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.\n\nUlinastatin 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.\n\nTherefore this is a randomized controlled trial to test the hypothesis of the preventive effect of ulinastatin in ARDS.\n\nThis is a multi-center, randomized, double blinded, placebo controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients should be more than 18 years old\n* Patients are expected to living within 72 hours of ICU admission\n* 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.\n\nExclusion Criteria: Patients will be excluded when they are\n\n* diagnosed as ARDS\n* without written informed consent\n* with HIV infection\n* with other immunologic deficiency (leukaemia, immune deficiency syndrome, etc)\n* with organ transplantation or bone marrow transplantation\n* with chronic pulmonary disease (except for Chronic Obstructive Pulmonary Disease (COPD) or asthma)\n* with angitis\n* with neutropenia (except for secondary to sepsis)\n* using granulocyte-macrophage colony-stimulating factor or granulocyte colony-stimulating factor\n* using asprin or clopidogrel\n* using glucocorticoid\n* withdrawing treatment\n* treated by Xuebijing, thymosin, or intravenous immunoglobulin 1 month before enrollment\n* enrolled in other clinical trials 3 months before enrollment\n* being pregnancy\n* being lactation"}, 'identificationModule': {'nctId': 'NCT03089957', 'briefTitle': 'Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Prevention of Ulinastatin on Acute Respiratory Distress Syndrome (ARDS) A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2016-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ulinastatin group', 'description': '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.', 'interventionNames': ['Drug: Ulinastatin', 'Other: Usual care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group will be in usual care without any intervention.', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Ulinastatin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Ulinastatin group']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual care in ICU.', 'armGroupLabels': ['Control group', 'Ulinastatin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital ,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Shijitan Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese Pla General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The first affiliated hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': "CANGZHOU People's Hospital", 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The second hospital of dalian medical university', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Zibo', 'state': 'Shandong', 'country': 'China', 'facility': 'Central Hospital of Zi Bo', 'geoPoint': {'lat': 36.79056, 'lon': 118.06333}}], 'overallOfficials': [{'name': 'Xi Zhu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All data will be shared with other researchers in papers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'Central Hospital of Zi Bo', 'class': 'UNKNOWN'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Beijing Shijitan Hospital Affiliated to Capital Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D. Chief physician', 'investigatorFullName': 'Zhu Xi', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}