Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01432093
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2011-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intensive Glycemic Management and Outcomes Following Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-11', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.', 'timeFrame': '90 days following liver transplantation.', 'description': 'The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.'}], 'secondaryOutcomes': [{'measure': 'Compare length of stay in the ICU and hospital in the two study groups.', 'timeFrame': '90 days following liver transplantation.'}, {'measure': 'Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.', 'timeFrame': '90 days following liver transplantation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['liver transplant', 'high blood sugars', 'hospital hyperglycemia', 'post-transplant hyperglycemia', 'post liver transplant', 'post liver-kidney transplant'], 'conditions': ['Hospital Hyperglycemia', 'Post-transplant Hyperglycemia']}, 'descriptionModule': {'briefSummary': "Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Undergoing liver transplant or combined liver-kidney transplant\n\nExclusion Criteria:\n\n* Unable to grant informed consent or comply with study procedure\n* Allergic to any of the excipients in insulin'}, 'identificationModule': {'nctId': 'NCT01432093', 'briefTitle': 'Intensive Glycemic Management and Outcomes Following Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11-002918'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive glycemic management', 'description': 'Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.', 'interventionNames': ['Other: Intensive glycemic management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional management', 'description': 'Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.', 'interventionNames': ['Other: Conventional management']}], 'interventions': [{'name': 'Intensive glycemic management', 'type': 'OTHER', 'description': 'Intravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.', 'armGroupLabels': ['Intensive glycemic management']}, {'name': 'Conventional management', 'type': 'OTHER', 'description': 'Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.', 'armGroupLabels': ['Conventional management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Gunjan Y. Gandhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gunjan Gandhi', 'investigatorAffiliation': 'Mayo Clinic'}}}}