Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-28 @ 6:00 AM
Study NCT ID:
NCT02726932
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2016-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010538', 'term': 'Peritonitis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'Death within 90 days of primary operation for diffuse peritonitis'}, {'measure': 'ICU admission', 'timeFrame': '90 days', 'description': 'Intensive Care Unit admission and length of ICU treatment'}, {'measure': 'Length of hospitalization', 'timeFrame': '90 days', 'description': 'Days in hospital postoperatively'}, {'measure': 'Reoperations', 'timeFrame': '90 days', 'description': 'Reoperations needed postoperatively'}, {'measure': 'Complications', 'timeFrame': '90 days', 'description': 'Postoperative complications according to Clavien-Dindo classification'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peritonitis', 'Inflammatory Markers', 'Patient Outcome Assessment', 'Classification', 'Multiple Organ Failure', 'Intraabdominal Infections'], 'conditions': ['Peritonitis']}, 'referencesModule': {'references': [{'pmid': '30976292', 'type': 'DERIVED', 'citation': 'Tolonen M, Sallinen V, Leppaniemi A, Backlund M, Mentula P. The role of the intra-abdominal view in complicated intra-abdominal infections. World J Emerg Surg. 2019 Mar 29;14:15. doi: 10.1186/s13017-019-0232-7. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients operated for complicated intra-abdominal infection in a single university hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\> 18 years old\n* operated for complicated intra-abdominal infection\n\nExclusion Criteria:\n\n* another diagnosis requiring ICU level care at the same time\n* acute pancreatitis\n* acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein\n* peritonitis due to timely diagnosed trauma\n* missing informed consent or inability to understand it'}, 'identificationModule': {'nctId': 'NCT02726932', 'acronym': 'PERICLASS', 'briefTitle': 'Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery', 'orgStudyIdInfo': {'id': 'Dnro 6/13/03/02/2016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention, merely observational', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Panu Mentula, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Matti Tolonen', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}