Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-25 @ 6:32 PM
Study NCT ID:
NCT06589102
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'All patients are followed until they leave the hospital, but a maximum of six months', 'description': 'hospital stay following surgery'}], 'secondaryOutcomes': [{'measure': 'General postoperative complications', 'timeFrame': 'All patients are followed until they leave the hospital, but a maximum of six months', 'description': 'Defined as Clavien-Dindo grade III-V'}, {'measure': 'ICU care', 'timeFrame': 'All patients are followed until they leave the hospital, but a maximum of six months', 'description': 'Organ failure requiring ICU care'}, {'measure': 'Surgery specific complications', 'timeFrame': '90 days', 'description': 'Pancreatic fistula, bile leakage, delayed gastric emptying'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic surgery'], 'conditions': ['Pancreatic Cancer', 'Pancreatic Cyst', 'Chronic Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the role of lactate elevation.\n\nThe main aims are:\n\n* Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications\n* Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients scheduled to undergo major pancreatic surgery in a tertiary university hospital during 2016-18', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing pancreatic surgery 2016-2018\n\nExclusion Criteria:\n\n* Patients unable to undergo scheduled surgery\n* Missing data in the postoperative period'}, 'identificationModule': {'nctId': 'NCT06589102', 'briefTitle': 'Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery', 'orgStudyIdInfo': {'id': '2019-04284'}}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Huddinge', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'Jonathan Grip', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}