Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-08 @ 4:26 AM
Study NCT ID:
NCT05502835
Status:
COMPLETED
Last Update Posted:
2023-01-30
First Post:
2022-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2022-08-02', 'studyFirstSubmitQcDate': '2022-08-15', 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative fluid volume', 'timeFrame': 'calculated immediately after surgery'}], 'secondaryOutcomes': [{'measure': 'intraoperative blood pressure', 'timeFrame': 'every ten minutes till the end of the surgery'}, {'measure': 'lactate level', 'timeFrame': 'every hour till the end of the surgery'}, {'measure': 'POSTOPERATIVE COMPLICATIONS', 'timeFrame': 'till one week after surgery'}, {'measure': 'intestinal oedema', 'timeFrame': 'intraoperatively after tumor resection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Fluid Volume', 'Hemodynamics', 'Serum Lactate', 'Intestinal Edema', 'Length of the Hospital Stay', 'First Time to Gastrointestinal Motion', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.', 'detailedDescription': "All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):\n\nGroup A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.\n\nGroup B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.\n\nIntraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'participant eligibility is based on self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.\n* Patients scheduled for elective open colonic mass resection and anastomosis.\n\nExclusion Criteria:\n\n* Serious cardiac arrhythmia.\n* Peripheral artery disease.\n* An ejection fraction below 30%.\n* A pulmonary pathology.'}, 'identificationModule': {'nctId': 'NCT05502835', 'briefTitle': 'Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis', 'orgStudyIdInfo': {'id': 'IRB00006379 GUT OEDEMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional fluid management group', 'description': "patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.", 'interventionNames': ['Other: conventional fluid management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ppv group', 'description': "patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.", 'interventionNames': ['Device: pulse pressure variation']}], 'interventions': [{'name': 'pulse pressure variation', 'type': 'DEVICE', 'description': "Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.", 'armGroupLabels': ['ppv group']}, {'name': 'conventional fluid management', 'type': 'OTHER', 'description': "Infusion of 6 ml/kg/hr. Ringer's solution.", 'armGroupLabels': ['conventional fluid management group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia', 'investigatorFullName': 'RAMY AHMED', 'investigatorAffiliation': 'Ain Shams University'}}}}