Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04112004
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2019-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}], 'ancestors': [{'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-01', 'size': 110538, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-29T02:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-29', 'studyFirstSubmitDate': '2019-06-30', 'studyFirstSubmitQcDate': '2019-09-29', 'lastUpdatePostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in serum sodium in liver transplant recipients', 'timeFrame': '1 day', 'description': 'difference between baseline and postoperative sodium in liver transplant recipients'}, {'measure': 'post transplant mortality', 'timeFrame': '1 month', 'description': 'post transplant mortality after liver transplantation'}], 'secondaryOutcomes': [{'measure': 'post operative neurological complications', 'timeFrame': '1 month', 'description': 'Post operative neurological complications after liver transplantation'}, {'measure': 'duration of mechanical ventilation', 'timeFrame': '1 month', 'description': 'duration of mechanical ventilation after liver transplantation'}, {'measure': 'Duration of hospital stay', 'timeFrame': '1 month', 'description': 'Hospital stay after liver transplantation'}, {'measure': 'Duration of ICU stay', 'timeFrame': '1 month', 'description': 'Duration of ICU stay after liver transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver transplantation', 'perioperative sodium', 'sodium'], 'conditions': ['Liver Transplant; Complications', 'Perioperative/Postoperative Complications', 'Electrolyte Disturbance']}, 'descriptionModule': {'briefSummary': 'We analyzed the association of delta sodium levels with their effect on post liver transplant outcomes in consecutive patients undergoing liver transplantation. Records were analyzed for electrolytes and outcome measures, and data was analyzed.', 'detailedDescription': 'Preoperative hyponatremia was identified in patients. The mean change in sodium in hyponatremic patients was compared with inpatients with normal sodium levels. The impact of the delta sodium levels with short-term outcomes, such as duration of intubation, intensive care unit length of stay were analyzed with univariate and multivariate logistic regression analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver transplant recipients more than 18 years in ILBS during study period', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All liver transplant recipients between Jan 2011 to Jan 2017\n* Records available\n\nExclusion Criteria:\n\n* Acute fulminant liver failure\n* All patients less than 18 years\n* Re operated cases\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT04112004', 'acronym': 'SOLT', 'briefTitle': 'Effect Of Delta Sodium on the Postoperative Outcomes in Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Effect of Perioperative Delta Sodium on Outcomes in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'ILBS - Liver Transplant-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver Transplant Recipients', 'description': 'All elective liver transplant recipients done between study period', 'interventionNames': ['Other: Collecting sodium reports and outcome measures']}], 'interventions': [{'name': 'Collecting sodium reports and outcome measures', 'type': 'OTHER', 'armGroupLabels': ['Liver Transplant Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Karthik T Ponnappan, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Liver and Biliary Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Karthik Ponnappan T', 'investigatorAffiliation': 'Institute of Liver and Biliary Sciences, India'}}}}