Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-02 @ 10:33 AM
Study NCT ID:
NCT05585866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2022-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000777', 'term': 'Anesthetics'}], 'ancestors': [{'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury', 'timeFrame': 'Within 10 days of surgery', 'description': 'Compare the incidence of AKI (n, %) in the two anesthetic modalities. Number of participants (n, %) with AKI and number of participants (n, %) with AKI stage 1-3 within the different anesthetic modalities at 0-3 days and 4-10 days postoperatively. KDIGO (Kidney Disease: Improving Global Outcome) criteria for plasma creatinine are used as criteria for AKI. The highest value of plasma creatinine within the time frame will be used to define AKI stage.'}, {'measure': 'Changes in plasma creatinine', 'timeFrame': 'Within 30 days of surgery', 'description': 'Changes in plasma creatinine over time in both groups of anesthesia. Plasma creatinine from preoperative, postoperative after 0-3 days, postoperative 4-10 days and after 30 days. Maximum plasma creatinine for each participant at these time point will be used in the regression analysis.'}], 'secondaryOutcomes': [{'measure': 'AKI incidence in the cardiovascular disease population', 'timeFrame': 'Within 10 days of surgery', 'description': 'Compare the incidence of AKI (n, %) during the two anesthetic modalities in the population with present cardiovascular disease. Classified according to KDIGO AKI stage 1-3 changes in plasma creatinine. The highest value of plasma creatinine within the time frame will be used to define AKI stage.'}, {'measure': 'Association of sex on AKI incidence', 'timeFrame': 'Within 10 days of surgery', 'description': 'Compare the incidence of AKI (n, %) in men vs women. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality.'}, {'measure': 'Association of age on AKI incidence', 'timeFrame': 'Within 10 days of surgery', 'description': 'Compare the incidence of AKI (n, %) in participants older vs younger than 65. This analysis will be done in both groups separately and in the entire population independent of anesthetic modality.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sevoflurane', 'propofol', 'plasma creatinine'], 'conditions': ['Acute Kidney Injury', 'Cancer Colorectal']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare anesthetic modalities (intravenous propofol anesthesia with sevoflurane gas anesthesia) in patients who underwent colorectal cancer resection surgery regarding the outcome of acute kidney injury.\n\nThe main questions it aims to answer are:\n\n* is there a difference in acute kidney injury incidence in the two anesthetic modalities?\n* is there a difference in plasma creatinine between the two anesthetic modalities?\n* are there any patient characteristics or intraoperative factors that effect the incidence of acute kidney injury in either anesthetic modality?\n\nThe study will analyze data from the CAN clinical trial database. (Cancer and Anesthesia: Survival After Radical Surgery - a Comparison Between Propofol or Sevoflurane Anesthesia, NCT01975064)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent colorectal cancer resection surgery and gave consent to participate in the CAN trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* colorectal surgery and participant in the CAN trial\n\nExclusion Criteria:\n\n* missing blood samples'}, 'identificationModule': {'nctId': 'NCT05585866', 'acronym': 'PROSACC', 'briefTitle': 'Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Propofol and Sevoflurane Anesthesia in Colorectal Cancer Surgery: Incidence of Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'PROSACC2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sevoflurane', 'description': 'The group of patients which received sevoflurane as randomized anesthetic modality.', 'interventionNames': ['Drug: Anesthesia Agent']}, {'label': 'Propofol', 'description': 'The group of patients which received propofol as randomized anesthetic modality.', 'interventionNames': ['Drug: Anesthesia Agent']}], 'interventions': [{'name': 'Anesthesia Agent', 'type': 'DRUG', 'description': 'The two anesthetic modalities included intravenous propofol anesthesia and sevoflurane gas anesthesia administered according to standard clinical praxis.', 'armGroupLabels': ['Propofol', 'Sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}