Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT04928859
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000418', 'term': 'Albumins'}, {'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mortality of the patients', 'timeFrame': "during the patients's hospitalization, an average of 1-2 month.", 'description': 'The mortality of the patients during their hospitalization.'}], 'secondaryOutcomes': [{'measure': "the length of the patients's hospital stay", 'timeFrame': "during the patients's hospitalization, an average of 1-2 month.", 'description': "the Length of the patients's hospital stay,an average of 1-2 month."}, {'measure': 'the number of patients that using ventilators', 'timeFrame': "during the patients's hospitalization, an average of 1-2 month.", 'description': 'the number of patients who using ventilators during their hospitalization'}, {'measure': "Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid", 'timeFrame': "during the patients's hospitalization, an average of 1-2 month.", 'description': 'the volume of the patients\'s resuscitation fluid using "mL" as the measurement'}, {'measure': 'the number of complications that the patients occurred', 'timeFrame': "during the patients's hospitalization, an average of 1-2 month.", 'description': 'the number of complications that the patients occurred during their hospitalization'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burns; shock; recovery; human albumin; effect'], 'conditions': ['Burns Shock']}, 'descriptionModule': {'briefSummary': 'To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.', 'detailedDescription': 'A retrospective case-control study was conducted. Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified. Patients were divided into two groups according to the severity of burns, the patients with a 20%\\<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA\\>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group. The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who admitted to the burn ward of the Second Affiliated Hospital, School of Medicine, Zhejiang University and needed fluid resuscitation were identified during the period of January 2011 to December 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* TBSA≥ 20% （TBSA，the total burn area.）\n* Admitted to hospital within 24 hours after injury.\n\nExclusion Criteria:\n\n* STB ≥ 33 μ mol/L\n* Cr ≥ 171 μ\n* Urine output l\\< 500 ml / 24 h\n* Pregnant and lactating women\n* Severe combined injury\n* Glucocorticoids users\n* Immunosuppressants users\n* Patients survived less than 48 hours'}, 'identificationModule': {'nctId': 'NCT04928859', 'briefTitle': 'Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery', 'orgStudyIdInfo': {'id': '2020-489'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the albumin group', 'description': 'The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group.', 'interventionNames': ['Drug: Albumin']}, {'label': 'the control group', 'description': 'The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control group.'}], 'interventions': [{'name': 'Albumin', 'type': 'DRUG', 'otherNames': ['human albumin'], 'description': 'At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group.\n\nThe patients who have no albumin use during their hospitalization in the burn ward consisted the control group.', 'armGroupLabels': ['the albumin group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hai-Bin Dai, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}