Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-07 @ 5:46 AM
Study NCT ID:
NCT06133257
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2023-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D020896', 'term': 'Hypovolemia'}, {'id': 'D012773', 'term': 'Shock, Surgical'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Blood Pressure', 'timeFrame': 'intraoperatively every 5 minutes', 'description': 'intraoperative mean arterial blood pressure measured in mmHg'}, {'measure': 'Quality of Recovery-40 score(QoR-40)', 'timeFrame': '24 hours postoperative', 'description': 'QoR-40 score ranges from 40 to 200, the higher the score the better the outcome'}, {'measure': 'Heart Rate', 'timeFrame': 'intraoperatively every 5 minutes', 'description': 'intraoperative heart rate will be continuously monitored and recorded every 5 minutes'}, {'measure': 'Post Anesthesia Care Unit(PACU) Stay', 'timeFrame': '2 hours postoperatively', 'description': 'time spent in PACU after surgery measured in minutes'}], 'secondaryOutcomes': [{'measure': 'Total fluid intake during operation', 'timeFrame': 'intraoperatively', 'description': 'Total fluid intake during operation'}, {'measure': 'Number of patients that needed Ephedrine or Atropine', 'timeFrame': 'intraoperatively', 'description': 'Number of patients that needed Ephedrine or Atropine intraoperatively'}, {'measure': 'Peripheral perfusion index', 'timeFrame': 'Intraoperatively', 'description': 'Peripheral Perfusion Index (PPI) is defined as "the ratio of pulsatile blood flow to the non-pulsatile blood flow". It ranges from 0.02% to 20% and it is measured using specific types pulse oximetry and it reflects the perfusion status of the body.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'the patient will be followed up for 60 days from day of surgery', 'description': "the number of days from day of surgery until patient's discharge from hospital"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia', 'ERAS', 'Fluid Overload', 'Hypovolemia; Surgical Shock']}, 'descriptionModule': {'briefSummary': 'Controlling the amount of fluids given to patients in perioperative setting can significantly influence their outcomes.', 'detailedDescription': 'To overcome these problems and avoid the complications of over or underhydration, we use the Goal-directed fluid therapy(GDFT) guided by Inferior vena cava(IVC) collapsibility index approach in which dynamic parameters of volume responsiveness as a guide for fluid therapy. This will ensure that the fluids given were deficient from the circulation and improve the recovery of the patients according to enhanced recovery after surgery(ERAS) protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient's acceptance.\n* Patients planned for elective lower limb surgery under spinal anesthesia.\n* Both sexes\n* Body Mass Index(BMI): \\<35\n* Age: 21 \\~ 65 years\n* American Society of Anesthesiologists(ASA) Physical Status Classification System: Class I \\& II\n* Duration of surgery 2\\~3 hours\n\nExclusion Criteria:\n\n* Advanced kidney, liver, respiratory or cardiovascular disease.\n* Contraindication for spinal anesthesia.\n* Patients shifted to general anesthesia for any reason."}, 'identificationModule': {'nctId': 'NCT06133257', 'briefTitle': 'Goal-Directed Fluid Therapy in Patients Undergoing Lower Limb Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Effects of Goal-Directed Fluid Therapy Guided by Inferior Vena Cava Collapsibility Index on Hemodynamics and Enhanced Recovery in Patients Undergoing Lower Limb Surgeries', 'orgStudyIdInfo': {'id': '11122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GD Group', 'description': 'Patients will take oral clear fluids with carbohydrates content 2 hours preoperatively and intraoperative fluid intake will be guided by Inferior vena cava(IVC) diameter.', 'interventionNames': ['Procedure: Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C Group', 'description': 'the standard fluid management group patients will be fasting 6 hours preoperatively and will receive intraoperative fluid in standard manner.', 'interventionNames': ['Procedure: standard fluid management']}], 'interventions': [{'name': 'Goal-Directed Fluid Therapy guided by Inferior Vena Cava Collapsibility Index', 'type': 'PROCEDURE', 'description': 'Measuring Inferior vena cava(IVC) diameter using ultrasound then calculation Inferior vena cava(IVC) collapsibility index and administer fluid accordingly.', 'armGroupLabels': ['GD Group']}, {'name': 'standard fluid management', 'type': 'PROCEDURE', 'description': 'standard fluid management', 'armGroupLabels': ['C Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Abdelkader, MBBCh', 'role': 'CONTACT', 'email': 'mahmoud.ab.ali@gmail.com', 'phone': '00201553638376'}, {'name': 'Alshaimaa Kamel, MD.', 'role': 'CONTACT', 'email': 'AlshaimaaKamel80@yahoo.com', 'phone': '01005593169', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Mahmoud Abdelkader, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia, Intensive Care and Pain Management department, Faculty of Medicine, Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor of anesthesia, Intensive Care and Pain Management', 'investigatorFullName': 'Mahmoud Aboubakr Abdelkader', 'investigatorAffiliation': 'Zagazig University'}}}}