Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2026-01-01 @ 1:15 AM
Study NCT ID:
NCT04794595
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'the volume of 2ml whole blood was stored in EDTA tube'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': '28 days after hospital discharge', 'description': 'The survival rate of children in 28 days after hospital discharge'}], 'secondaryOutcomes': [{'measure': 'The creatinine level of non-survival children with sepsis', 'timeFrame': '28 days after hospital discharge', 'description': 'The creatinine level of non-survival children with sepsis in 28 days after hospital discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuous renal replacement therapy', 'sepsis', 'timing'], 'conditions': ['Sepsis', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'The effect of continuous blood purification (CBP) in children is unclear. Also, the timing of early application is still being explored. In this study, we need to explore the efficacy and the timing of application of CBP in children with sepsis or septic shock.', 'detailedDescription': "Early intervention of CBP can remove inflammatory factors in patients with sepsis and reduce the damage of inflammatory factors to organs; at the same time, it can also promote the body's immune response, significantly improve immune dysfunction, and restore the body's immune balance. However, the timing of early application of CBP in childhood sepsis is still unclear. Therefore, it is necessary to further explore the treatment and prognosis of this technology in the early treatment of sepsis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '28 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children with sepsis requiring blood purification to prevent or treat fluid overload or to clear cytokines', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of 29d to 18 years old;\n* Children diagnosed with sepsis requiring blood purification.\n\nExclusion Criteria:\n\n* with a history of a duration of PICU stay \\<24 h\n* active bleeding, including cerebral hemorrhage'}, 'identificationModule': {'nctId': 'NCT04794595', 'briefTitle': 'Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Clinical Features and Outcomes of Continuous Blood Purification Versus Non-continuous Blood Purification in Pediatric Patients With Sepsis or Septic Shock', 'orgStudyIdInfo': {'id': 'fdpicu-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sepsis group with CBP', 'description': 'The child with sepsis should be treated with CBP， but could not receive this treatment for various reasons', 'interventionNames': ['Procedure: CBP']}, {'label': 'sepsis group without CBP', 'description': 'The child with sepsis should be treated with CBP and received this treatment'}], 'interventions': [{'name': 'CBP', 'type': 'PROCEDURE', 'otherNames': ['traditional therapy'], 'description': 'continuous blood purification can prevent or treat fluid overload in children with septic shock or other sepsis-associated organ dysfunction who are unresponsive to fluid restriction and diuretic therapy management of septic AKI patients, particularly those with hemodynamic instability or fluid overload. Also, it can remove cytokines', 'armGroupLabels': ['sepsis group with CBP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YING JIAYUN', 'role': 'CONTACT', 'email': 'jiayundoctor@163.com', 'phone': '18817583962'}], 'facility': "Children'S Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'YING JIAYUN', 'role': 'CONTACT', 'email': 'jiayundoctor@163.com', 'phone': '18817583962'}], 'overallOfficials': [{'name': 'Lu guoing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai Children's Hospital", 'class': 'OTHER'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}