Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-03 @ 5:26 PM
Study NCT ID:
NCT06595667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015192', 'term': 'Infratentorial Neoplasms'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002496', 'term': 'Central Venous Pressure'}], 'ancestors': [{'id': 'D014690', 'term': 'Venous Pressure'}, {'id': 'D001794', 'term': 'Blood Pressure'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor received the anesthetic record form by unknown of the patient and group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two study groups are parallel according to the block of four randomization.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'vasopressor requirement', 'timeFrame': 'during surgery and 48 hours at the neurosurgical ICU', 'description': 'type and amount of vasoactive medication'}, {'measure': 'length of neurosurgical ICU stay', 'timeFrame': 'from date of randomization to the day of being discharged from ICU or up to 1 week after surgery, depended on which happen first', 'description': 'days of ICU stay'}], 'primaryOutcomes': [{'measure': 'Total intraoperative fluid administration volumes during surgery', 'timeFrame': 'during surgery', 'description': 'fluid and blood and blood volume transfusion during surgery'}], 'secondaryOutcomes': [{'measure': 'vital signs', 'timeFrame': 'during surgery, the data will be recorded every 5 minutes throughout the procedure', 'description': 'blood pressure both systolic and diastolic pressure'}, {'measure': 'vital signs', 'timeFrame': 'during the admission in neurosurgical ICU up to 3 days after surgery', 'description': 'blood pressure both systolic and diastolic pressure'}, {'measure': 'time to extubation', 'timeFrame': '48 hours after surgery at the neurosurgical intensive care unit', 'description': 'to be able to succesfully extubated, count time period of using ventilator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkbench position', 'posterior fossa tumor', 'pulse pressure variation', 'fluid responsiveness'], 'conditions': ['Posterior Fossa Tumor', 'Brain Tumor Adult']}, 'referencesModule': {'references': [{'pmid': '40455866', 'type': 'DERIVED', 'citation': 'Pin On P, Kacha S, Saringkarinkul A, Thanakititham N. Study protocol for a randomized controlled trial comparing pulse pressure variation (PPV) and central venous pressure (CVP) guidance for fluid responsiveness assessment in neurosurgical patients undergoing posterior fossa tumor resection in park bench position. PLoS One. 2025 Jun 2;20(6):e0324590. doi: 10.1371/journal.pone.0324590. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To answer the question: What are the differences in intraoperative fluid administration volumes between PPV and CVP-guided strategies during posterior fossa tumor resection in the park bench position?', 'detailedDescription': 'Prospective RCT is conducted to compared the amount of fluid volume in adult patients undergoing posterior fossa surgery in park bench position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients aged 18 years and above\n2. American Society of Anesthesiologists (ASA) I and II\n3. Diagnosis of posterior fossa tumor requiring surgical resection in the park bench position, under general anesthesia at our hospital\n4. Willing to participate in the study\n\nExclusion Criteria:\n\n1. Arrhythmia\n2. Significant cardiac diseases\n3. Chronic obstructive airway disease\n4. Elevated intra-abdominal pressure\n5. Tumors prone to precipitate diabetes insipidus\n6. Peripheral vascular disease\n7. Pulmonary hypertension\n8. Patients in sepsis'}, 'identificationModule': {'nctId': 'NCT06595667', 'briefTitle': 'Fluid Responsiveness in Posterior Fossa Tumor Resection: PPV and CVP Guidance', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Fluid Responsiveness Assessment in Adult Neurosurgical Patients Undergoing Posterior Fossa Tumor Resection in the Park Bench Position: a Comparison Between Pulse Pressure Variation (PPV) and Central Venous Pressure (CVP) Guidance', 'orgStudyIdInfo': {'id': 'ANE-2567-0391'}, 'secondaryIdInfos': [{'id': 'Chiang Mai University', 'type': 'OTHER', 'domain': 'Chiang Mai University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulse pressure variation guidance fluid administration', 'description': 'In the PPV group, fluids will be administered to maintain the PPV below 13%. If hypotension coincided with a PPV exceeding 13%, an initial bolus of 200 ml crystalloid fluid solution will be given in10 minutes. PPV reassessment occurred within the subsequent 10 minutes. Alternatively, if hypotension occurs with a PPV measuring less than 13%, vasopressors such as ephedrine at a dose of 3-6 mg or norepinephrine at a dosage of 5-10 mcg intravenously as a bolus, or norepinephrine infusion at a rate of 0.03-0.3 mcg/kg/min, will be given to sustain mean arterial pressure above 65 mmHg.', 'interventionNames': ['Procedure: Pulse pressure variation']}, {'type': 'EXPERIMENTAL', 'label': 'Central venous pressure guidance fluid administration', 'description': 'In the CVP group, intraoperative fluid administration aimed to maintain CVP between 8-12 cmH2O while on mechanical ventilation, ensuring mean arterial pressure remains above 65 mmHg and heart rate within 20% of baseline.', 'interventionNames': ['Procedure: Central venous pressure']}], 'interventions': [{'name': 'Pulse pressure variation', 'type': 'PROCEDURE', 'otherNames': ['PPV'], 'description': 'Fluid administration during posterior fossa surgery in the parkbench position is guided by the PPV value.', 'armGroupLabels': ['Pulse pressure variation guidance fluid administration']}, {'name': 'Central venous pressure', 'type': 'PROCEDURE', 'otherNames': ['CVP'], 'description': 'Fluid administration during posterior fossa surgery in the parkbench position is guided by the CVP value.', 'armGroupLabels': ['Central venous pressure guidance fluid administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Pathomporn P Pin on, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Pathomporn Pin on', 'investigatorFullName': 'Pathomporn Pin on, M.D.', 'investigatorAffiliation': 'Chiang Mai University'}}}}