Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 9:46 AM
Study NCT ID:
NCT05957003
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness in Post-cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of volume responder participants could be detected using each fluid responsiveness test', 'timeFrame': 'immediate postoperative period', 'description': 'The number of volume responder participants could be detected using each fluid responsiveness test including tidal volume challenge test and combined end-expiratory occlusion and end-inspiratory occlusion test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fluid Overload', 'Cardiac Surgery', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients', 'detailedDescription': 'multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.\n\nFurthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on mechanical ventilation\n* Patients ≥18 years of age\n* patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)\n* patients with normal systolic function of the left and right ventricle\n* patient is mechanically ventilated with a protective lung strategy\n\nExclusion Criteria:\n\n* Patients with Spontaneously breathing activity\n* Patients undergoing emergent cardiac surgery.\n* Patient with severe peripheral arterial occlusive disease\n* Pregnant women\n* Contraindication of passive leg raising test\n* unstable post-operative course\n* Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;\n* presence of residual severe tricuspid or any valvular regurgitations\n* low cardiac output, low ejection fractions (EF ≤45%)\n* open chest,Pao2/Fio2 ≤ 200'}, 'identificationModule': {'nctId': 'NCT05957003', 'briefTitle': 'Fluid Responsiveness in Post-cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'The Validity of Combined End-expiratory and End-inspiratory Occlusion Test and Tidal Volume Challenge Test for Prediction of Fluid Responsiveness in Immediate Post-cardiac Surgery Patients', 'orgStudyIdInfo': {'id': 'fluid responsiveness'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'occlusions test', 'description': 'Combined end expiratory (EEO) and inspiratory occlusion (EIO) test. A 15-s EEO separated by a time window of 1 minute to allow the hemodynamic parameters to return to baseline followed by a 15-s EIO', 'interventionNames': ['Procedure: Combined end-expiratory occlusion and end-inspiratory occlusion test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'challenge test', 'description': 'Tidal volume (TV) challenge test (transient increase of TV from 6 to 8 mL/kg for 1 minute)', 'interventionNames': ['Procedure: Tidal volume challenge test']}], 'interventions': [{'name': 'Combined end-expiratory occlusion and end-inspiratory occlusion test', 'type': 'PROCEDURE', 'description': 'The EEO test will be performed by interrupting the mechanical ventilation at end-expiration over 15 seconds using the end-expiratory hold button available on the ventilator.\n\nThe EIO test will be performed by interrupting the mechanical ventilation at end-inspiration over 15 seconds using the end-inspiratory hold button available on the ventilator.', 'armGroupLabels': ['occlusions test']}, {'name': 'Tidal volume challenge test', 'type': 'PROCEDURE', 'description': 'elevating tidal volume from 6 ml/kg to 8 ml/kg for only 60 seconds', 'armGroupLabels': ['challenge test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'El Gharbyia', 'country': 'Egypt', 'facility': 'Faculty of medicine, Tanta university', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'tarek abdel hay mostafa', 'investigatorAffiliation': 'Tanta University'}}}}