Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-26 @ 5:29 PM
Study NCT ID:
NCT01303250
Status:
TERMINATED
Last Update Posted:
2015-12-18
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'The final decision of the review of HES-containing solution shall be awaited.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of administered fluids', 'timeFrame': 'intraoperatively', 'description': 'Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized'}], 'secondaryOutcomes': [{'measure': 'Incidence of surgery related complications', 'timeFrame': 'day 28 and 90 postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['goal-directed fluid optimization', 'hemodynamic optimization', 'crystalloid', 'colloid'], 'conditions': ['Surgery, Colorectal']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation \\<= 12%.\n\nThe investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing elective colorectal surgery\n* minimum age 18 years\n* informed consent\n\nExclusion Criteria:\n\n* patients with severe cardiomyopathy or severe heart failure\n* history of coagulation disorders\n* intracranial hemorrhage\n* patients with severe cardiovascular or respiratory disorders\n* renal insufficiency\n* severe liver diseases'}, 'identificationModule': {'nctId': 'NCT01303250', 'acronym': 'KoKris', 'briefTitle': 'Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery', 'orgStudyIdInfo': {'id': 'UKM09_0031'}, 'secondaryIdInfos': [{'id': '2009-017595-25', 'type': 'EUDRACT_NUMBER'}, {'id': '04-AnIt-09', 'type': 'OTHER', 'domain': 'Department of Anesthesiology, University Hospital Muenster'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'A balanced hydroxyethyl starch 130/0.4 will be used', 'interventionNames': ['Drug: balanced 6% hydroxyethylstarch 130/0.4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'A balanced crystalloid will be used', 'interventionNames': ['Drug: balanced crystalloid']}], 'interventions': [{'name': 'balanced 6% hydroxyethylstarch 130/0.4', 'type': 'DRUG', 'description': 'Fluid administration and optimization based on cardiac output findings during surgery.', 'armGroupLabels': ['Group 1']}, {'name': 'balanced crystalloid', 'type': 'DRUG', 'description': 'Fluid administration and optimization based on cardiac output findings during surgery.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Hugo Van Aken, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia and Intensive Care, University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}