Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 12:59 AM
Study NCT ID:
NCT07069894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5400}, 'targetDuration': '28 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day all-cause mortality', 'timeFrame': '28 days after enrollment'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'From Intensive Care Unit (ICU) admission to ICU discharge or death, up to 28 days.'}, {'measure': 'Ventilator-free days', 'timeFrame': '28 days after enrollment'}, {'measure': 'ICU-free days within 28 days', 'timeFrame': '28 days after enrollment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Xuebijing injection', 'Intensive Care Unit'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '32653650', 'type': 'BACKGROUND', 'citation': 'Ma Q, Qiu M, Zhou H, Chen J, Yang X, Deng Z, Chen L, Zhou J, Liao Y, Chen Q, Zheng Q, Cai L, Shen L, Yang Z. The study on the treatment of Xuebijing injection (XBJ) in adults with severe or critical Corona Virus Disease 2019 and the inhibitory effect of XBJ against SARS-CoV-2. Pharmacol Res. 2020 Oct;160:105073. doi: 10.1016/j.phrs.2020.105073. Epub 2020 Jul 9. No abstract available.'}, {'pmid': '34412743', 'type': 'BACKGROUND', 'citation': 'Liu X, Song Y, Guan W, Qiu H, Du B, Li Y, Liu Y, Shang H, Zhong N, Coronavirus Disease Emergency Project Research Collaboration G. [A multicenter prospective cohort study of Xuebijing injection in the treatment of severe coronavirus disease 2019]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Jul;33(7):774-778. doi: 10.3760/cma.j.cn121430-20210514-00714. Chinese.'}, {'pmid': '31162191', 'type': 'BACKGROUND', 'citation': 'Song Y, Yao C, Yao Y, Han H, Zhao X, Yu K, Liu L, Xu Y, Liu Z, Zhou Q, Wang Y, Ma Z, Zheng Y, Wu D, Tang Z, Zhang M, Pan S, Chai Y, Song Y, Zhang J, Pan L, Liu Y, Yu H, Yu X, Zhang H, Wang X, Du Z, Wan X, Tang Y, Tian Y, Zhu Y, Wang H, Yan X, Liu Z, Zhang B, Zhong N, Shang H, Bai C. XueBiJing Injection Versus Placebo for Critically Ill Patients With Severe Community-Acquired Pneumonia: A Randomized Controlled Trial. Crit Care Med. 2019 Sep;47(9):e735-e743. doi: 10.1097/CCM.0000000000003842.'}, {'pmid': '37126332', 'type': 'BACKGROUND', 'citation': 'Liu S, Yao C, Xie J, Liu H, Wang H, Lin Z, Qin B, Wang D, Lu W, Ma X, Liu Y, Liu L, Zhang C, Xu L, Zheng R, Zhou F, Liu Z, Zhang G, Zhou L, Liu J, Fei A, Zhang G, Zhu Y, Qian K, Wang R, Liang Y, Duan M, Wu D, Sun R, Wang Y, Zhang X, Cao Q, Yang M, Jin M, Song Y, Huang L, Zhou F, Chen D, Liang Q, Qian C, Tang Z, Zhang Z, Feng Q, Peng Z, Sun R, Song Z, Sun Y, Chai Y, Zhou L, Cheng C, Li L, Yan X, Zhang J, Huang Y, Guo F, Li C, Yang Y, Shang H, Qiu H; EXIT-SEP Investigators. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis: The EXIT-SEP Randomized Clinical Trial. JAMA Intern Med. 2023 Jul 1;183(7):647-655. doi: 10.1001/jamainternmed.2023.0780.'}, {'pmid': '31804299', 'type': 'BACKGROUND', 'citation': 'Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.'}, {'pmid': '31954465', 'type': 'BACKGROUND', 'citation': 'Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': "Xuebijing injection (XBJ) showed proven efficacy in the EXIT-SEP trial (NCT03238742), lowering 28-day mortality. However, its real-world effectiveness requires validation due to the trial's strict criteria. Broader clinical evaluation is imperative.", 'detailedDescription': "Sepsis is a life-threatening syndrome caused by a dysregulated response to infection, affecting an estimated 49 million people and claiming 11 million lives globally each year. Xuebijing injection (XBJ) has demonstrated efficacy in improving outcomes. A large multicenter randomized controlled trial (EXIT-SEP) confirmed that XBJ significantly reduces 28-day mortality. However, the trial population was relatively selected (aged 18-75 years, SOFA score 2-13), leaving its effectiveness in complex, real-world settings unclear. Therefore, further investigation of XBJ's impact in broader clinical practice is essential."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with sepsis (Sepsis-3 criteria) upon ICU admission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients aged ≥18 years\n* Sepsis diagnosis meeting Sepsis-3 criteria\n* Informed consent signed by patient or legally authorized representative\n\nExclusion Criteria:\n\n* Patients with a prior history of sepsis\n* Sepsis diagnosis \\>48 hours prior to enrollment\n* Current participation in clinical trial'}, 'identificationModule': {'nctId': 'NCT07069894', 'acronym': 'EXIT-SEP REAL', 'briefTitle': 'Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL）', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions: A Patient Registry', 'orgStudyIdInfo': {'id': '2025ZDSYLL252-P01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Xuebijing Group', 'description': 'The Xuebijing group consisted of sepsis patients who received both Xuebijing injection and guideline-concordant therapy. Researchers did not provide any additional interventions, but instead observed and documented the clinical outcomes and treatment effects of Xuebijing injection in combination with standard therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Professor Liu Songqiao', 'role': 'CONTACT', 'email': 'liusongqiao@ymail.com', 'phone': '+86 25 83262553'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Songqiao Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}