Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT03475732
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of XueBiJing in Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549376', 'term': 'Xuebijing'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-01', 'studyFirstSubmitDate': '2018-03-18', 'studyFirstSubmitQcDate': '2018-03-18', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of XueBiJing injection compounds', 'timeFrame': 'On 1stand 5th day of giving XueBiJing injection: pre-dose, 1.25 h after starting the infusion, and 0.5, 1, 2, 4, and 8 h after terminating the infusion On 2nd to 4th day of giving XueBiJing injection: pre-dose and 1.25 h after starting the infusion', 'description': 'Plasma concentrations of XueBiJing injection compounds'}], 'secondaryOutcomes': [{'measure': 'Accumulative amounts of XueBiJing compounds in urine', 'timeFrame': 'On 1st day of giving XueBiJing injection: pre-dose and 0-3.25 and 3.25-12 h after starting the infusion On 5thday of giving XueBiJing injection:0-3.25 and 3.25-12 h after starting the infusion', 'description': 'Accumulative amounts of XueBiJing compounds in urine'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XueBiJing injection', 'Sepsis', 'Septic shock', 'Pharmacokinetics'], 'conditions': ['Sepsis', 'Septic Shock', 'Community Acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '17448282', 'type': 'BACKGROUND', 'citation': 'Li YP, Qiao YJ, Wu ZX, Yao YM, Yu Y, Wu Y. [Effects of Xuebijing injection on high-mobility group box chromosomal protein 1 in septic rats]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2007 Apr;19(4):239-41. No abstract available. Chinese.'}, {'pmid': '26903338', 'type': 'BACKGROUND', 'citation': 'Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.'}, {'pmid': '26838074', 'type': 'BACKGROUND', 'citation': 'Cheng C, Lin JZ, Li L, Yang JL, Jia WW, Huang YH, Du FF, Wang FQ, Li MJ, Li YF, Xu F, Zhang NT, Olaleye OE, Sun Y, Li J, Sun CH, Zhang GP, Li C. Pharmacokinetics and disposition of monoterpene glycosides derived from Paeonia lactiflora roots (Chishao) after intravenous dosing of antiseptic XueBiJing injection in human subjects and rats. Acta Pharmacol Sin. 2016 Apr;37(4):530-44. doi: 10.1038/aps.2015.103. Epub 2016 Feb 1.'}, {'pmid': '26830081', 'type': 'BACKGROUND', 'citation': 'Li X, Cheng C, Wang F, Huang Y, Jia W, Olaleye OE, Li M, Li Y, Li C. Pharmacokinetics of catechols in human subjects intravenously receiving XueBiJing injection, an emerging antiseptic herbal medicine. Drug Metab Pharmacokinet. 2016 Feb;31(1):95-98. doi: 10.1016/j.dmpk.2015.10.005. Epub 2015 Nov 4.'}, {'pmid': '22519600', 'type': 'BACKGROUND', 'citation': 'Sinnollareddy MG, Roberts MS, Lipman J, Roberts JA. beta-lactam pharmacokinetics and pharmacodynamics in critically ill patients and strategies for dose optimization: a structured review. Clin Exp Pharmacol Physiol. 2012 Jun;39(6):489-96. doi: 10.1111/j.1440-1681.2012.05715.x.'}, {'pmid': '25038549', 'type': 'BACKGROUND', 'citation': 'Blot SI, Pea F, Lipman J. The effect of pathophysiology on pharmacokinetics in the critically ill patient--concepts appraised by the example of antimicrobial agents. Adv Drug Deliv Rev. 2014 Nov 20;77:3-11. doi: 10.1016/j.addr.2014.07.006. Epub 2014 Jul 15.'}, {'pmid': '24987833', 'type': 'BACKGROUND', 'citation': 'Harvey RD, Morgan ET. Cancer, inflammation, and therapy: effects on cytochrome p450-mediated drug metabolism and implications for novel immunotherapeutic agents. Clin Pharmacol Ther. 2014 Oct;96(4):449-57. doi: 10.1038/clpt.2014.143. Epub 2014 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'Pharmacokinetics and disposition of XueBiJing compounds in patients with sepsis', 'detailedDescription': "XueBiJing injection, a five-herb combination approved by Chinese FDA in 2004, has been widely used as an add-on therapy in routine sepsis care in Chinese clinics. A comprehensive pharmacokinetic research on this herbal injection has been conducted in healthy human subjects, and the major circulating XueBiJing compounds, as well as their systemic exposure levels and forms and pharmacokinetic characteristics, have been identified. However, it is known that sepsis may induce hepatic, renal and cardiac dysfunction, alter drug metabolizing enzymes and transporters activities, increase capillary permeability, and induce various pathophysiological changes. All these will affect the concentrations at the action sites and pharmacokinetic characteristics of XueBiJing compounds, which contribute to the injection's overall therapeutic action, thus influencing the anti-septic efficacy of the injection. The purpose of this prospective, open label study is to identify the circulating XueBiJing compounds in patients with sepsis after intravenously dosing XueBiJing injection and their systemic exposure forms and levels, pharmacokinetic characteristics, and the associated inter-patient differences of these XueBiJing compounds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18≤ age ≤70 years old\n* Community acquired pneumonia patients who met the Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM) with2 ≤SOFA ≤13\n* To use XueBiJing injection as an add-on therapy to treat sepsis decided byclinician\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Diagnosis of sepsis for over 48 h\n* Pregnant or lactating women\n* Patients with a history of anaphylaxis or allergyto XueBiJing or its component herbs\n* Patients participated in an investigational clinical trial within 30 days prior to this study\n* Patients unable or unsuitable to participate in this study decided by the investigator (i.e., patients whose death are deemed within 48 h or who poorly adhere to the treatment)'}, 'identificationModule': {'nctId': 'NCT03475732', 'briefTitle': 'Pharmacokinetics of XueBiJing in Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Pharmacokinetic Study of XueBiJing Injection in Patients With Sepsis', 'orgStudyIdInfo': {'id': '2017ZDSYLL123-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XueBiJing injection', 'description': '100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days', 'interventionNames': ['Drug: XueBiJing injection']}], 'interventions': [{'name': 'XueBiJing injection', 'type': 'DRUG', 'otherNames': ['Tianjin Chase Sun Pharmaceutical Co. LTD'], 'description': '100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days', 'armGroupLabels': ['XueBiJing injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Chuan Li, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Institute of Materia Medica, Chinese Academy of Sciences,China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will work on it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Songqiao Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}