Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT06814561
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Determinants of Urine Output During Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009846', 'term': 'Oliguria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter-Assisted Urine Output Measurement Post-Spinal Anesthesia', 'timeFrame': '10, 20, 30, 40, 50, and 60 minutes post-surgical intervention.', 'description': 'Urine volume is accurately measured using a catheter connected to a graduated collection bag. This method tracks the accumulated volume at specific intervals, providing a precise assessment of renal function and fluid management efficacy following spinal anesthesia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urine output', 'spinal anesthesia', 'mean arterial pressure'], 'conditions': ['Urine Output Decreased']}, 'descriptionModule': {'briefSummary': "This clinical trial investigates the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia. The study aims to validate observations from animal models in humans by concurrently measuring hemoglobin levels, MAP, and urine output, focusing on the effects of Ringer's solution, to provide crucial insights into optimal fluid management during anesthesia with minimal complexity.", 'detailedDescription': "The proposed clinical trial aims to explore the relationship between urine output and mean arterial pressure (MAP) during spinal anesthesia, a subject that has not been thoroughly studied in humans despite previous research under general anesthesia. Studies have demonstrated that the diuretic response to intravenous volume loading, using Ringer's solution or 20% albumin, varies with MAP levels. Specifically, Ringer's solution shows a greater diuretic effect when MAP exceeds 70 mmHg, whereas 20% albumin is more effective at lower pressures. This differential response highlights the importance of considering MAP in the choice of fluid for managing hypovolemia and oliguria.\n\nThe study's relevance is highlighted by the physiological dynamics at play, particularly how high levels of anesthesia, which influence the sympathetic nervous system from the mid-thoracic region, might reduce MAP and consequently decrease urine output. While this hypothesis has been examined in animal studies, its validity in humans remains unconfirmed.\n\nTo address this, the trial will measure hemoglobin levels, MAP, and urine output simultaneously, aiming to establish a clear correlation among these variables during spinal anesthesia. This methodical approach seeks to yield significant insights with minimal additional effort, contrasting with the complexities inherent in more elaborate study designs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients requiring spinal anesthesia for vascular surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent provided by patients or their legally authorized representatives.\n* Adults aged 18 years and older.\n\nExclusion Criteria:\n\n* Contraindications to Spinal Anesthesia:\n\n * Patient refusal\n * Presence of coagulopathy.\n * Current use of anticoagulant or antiplatelet medications.\n * Critical or severe aortic stenosis or other fixed cardiac output states.\n * High risk of infection at the spinal needle insertion site.\n * Elevated intracranial pressure.\n * Allergy\n * Sepsis\n* Procedures Not Amenable to Spinal Anesthesia:\n\n * Planned concurrent procedures that cannot be performed under spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT06814561', 'briefTitle': 'Hemodynamic Determinants of Urine Output During Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu'}, 'officialTitle': 'Hemodynamic Determinants of Urine Output During Spinal Anesthesia', 'orgStudyIdInfo': {'id': '2511'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Marcaine 0.5% Solution for Injection', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'The study involves the administration of 0.5% Marcaine heavy for spinal anesthesia in patients undergoing vascular surgery. The aim is to assess how this anesthesia affects urine output relative to mean arterial pressure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': '"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}], 'overallOfficials': [{'name': 'Robert Hahn, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment'}, {'name': 'Serban-Ion Bubenek-Turconi, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CC Iliescu Cardiovascular Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Balan Ion Cosmin', 'investigatorAffiliation': 'Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu'}}}}