Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-04 @ 12:46 PM
Study NCT ID:
NCT03408457
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2018-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of antibiotic', 'timeFrame': '2 days', 'description': 'ug/mL'}], 'secondaryOutcomes': [{'measure': 'Surgical wound infection', 'timeFrame': '30 days', 'description': 'Incidence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical wound infection', 'antibiotic concentration', 'blood level'], 'conditions': ['Antibiotic', 'Anti-Bacterial Agents', 'Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'This study evaluates antibiotic serum concentrations in correlation with perioperative fluid balance. Patients will be recruited in rectum and esophageal surgery (representative for low blood loss and restrictive fluid management) and in liver surgery (representative for high blood loss and liberal fluid management). The hypothesis is that high blood loss and liberal fluid management dilute antibiotic serum concentrations thereby potentially increasing surgical site infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical Patients of the University Medical Center Mainz', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery of rectom, esophagus or liver with indication for a central venous catheter\n* informed consent\n\nExclusion Criteria:\n\n* pregnancy\n* medical emergency\n* participation in another study'}, 'identificationModule': {'nctId': 'NCT03408457', 'briefTitle': 'Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Influence of Perioperative Fluid Balance on Serum Concentrations of Antibiotics and Surgical Site Infections', 'orgStudyIdInfo': {'id': '837.402.17 (11236)'}, 'secondaryIdInfos': [{'id': 'U1111-1207-8265', 'type': 'REGISTRY', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Blood sampling after antibiotic administration', 'type': 'PROCEDURE', 'description': 'Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Medical Center of the Johannes Gutenberg-University Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Serge C Thal, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center of the Johannes Gutenberg-University Mainz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Serge Thal', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}