Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT03220620
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Influence of perioperative fluid therapy on hemoglobin levels', 'timeFrame': 'during surgery', 'description': 'Influence of perioperative fluid therapy on hemoglobin levels'}, {'measure': 'Influence of perioperative fluid therapy on Methemoglobin levels', 'timeFrame': 'during surgery', 'description': 'Influence of perioperative fluid therapy on Methemoglobin levels'}], 'secondaryOutcomes': [{'measure': 'Influence of perioperative fluid therapy on changes in lactate', 'timeFrame': 'during surgery', 'description': 'Influence of perioperative fluid therapy on changes in lactate'}, {'measure': 'Influence of perioperative fluid therapy on SvO2', 'timeFrame': 'during surgery', 'description': 'Influence of perioperative fluid therapy on SvO2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluid therapy', 'perioperative', 'hemodilution'], 'conditions': ['Perioperative/Postoperative Complications', 'Fluid Overload', 'Hemoglobin H']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.', 'detailedDescription': "Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.\n\nAnother potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing major abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major abdominal surgery\n* informed consent\n\nExclusion Criteria:\n\n* violation of study protocol'}, 'identificationModule': {'nctId': 'NCT03220620', 'briefTitle': 'Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Rostock'}, 'officialTitle': 'Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery', 'orgStudyIdInfo': {'id': 'A 2017-0073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GDT Group', 'description': 'receives goal-directed therapy', 'interventionNames': ['Other: GDT']}, {'label': 'Not GDT Group', 'description': 'receives no individualized goal-directed therapy'}], 'interventions': [{'name': 'GDT', 'type': 'OTHER', 'description': 'individualized fluid therapy', 'armGroupLabels': ['GDT Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18057', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'University of Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Thomas Mencke, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rostock'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rostock', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Thomas Mencke', 'investigatorAffiliation': 'University of Rostock'}}}}