Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-06-10 @ 11:04 PM
Study NCT ID:
NCT02113358
Status:
UNKNOWN
Last Update Posted:
2014-12-03
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'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': 'C485123', 'term': 'HES 130-0.4'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum S100B protein', 'timeFrame': 'Changes from preoperative to postoperative day 2'}, {'measure': 'serum NGAL level', 'timeFrame': 'Changes from preoperative to postoperative day 2.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks'}, {'measure': 'Postoperative complications rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks'}, {'measure': 'Total intraoperative intravenous fluid administrated', 'timeFrame': 'During the surgical time, an expected average of 3 to 5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fluid therapy', 'neurosurgery'], 'conditions': ['Supratentorial Neoplasms', 'Brain Tumor, Primary', 'Craniotomy']}, 'referencesModule': {'references': [{'pmid': '28981592', 'type': 'DERIVED', 'citation': 'Wu CY, Lin YS, Tseng HM, Cheng HL, Lee TS, Lin PL, Chou WH, Cheng YJ. Comparison of two stroke volume variation-based goal-directed fluid therapies for supratentorial brain tumour resection: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):934-942. doi: 10.1093/bja/aex189.'}]}, 'descriptionModule': {'briefSummary': 'Fluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability.\n\nRecently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV \\<10% presenting the "normovolemia" group. The other group of patients will be kept intraoperative SVV \\<18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the "restrictive" group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Supratentorial brain tumor receiving elective craniotomy\n* BMI between 18.5-27.0 kg.m-2\n\nExclusion Criteria:\n\n* Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation;\n\n * NYHA class II\n* Renal dysfunction, eGFR\\< 60 ml.min-1.1.73m-2\n* Pulmonary cormorbidity, such as COPD'}, 'identificationModule': {'nctId': 'NCT02113358', 'briefTitle': 'Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201312116RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normovolemic group (keeping SVV<10% in supine; <15% in prone)', 'description': '1. The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia.\n2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.\n3. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.', 'interventionNames': ['Drug: Intravenous colloid bolus with Voluven']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restricitve group (keeping SVV < 18% in supine; <23% in prone)', 'description': '1. The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia.\n2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.\n3. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.', 'interventionNames': ['Drug: Intravenous colloid bolus with Voluven']}], 'interventions': [{'name': 'Intravenous colloid bolus with Voluven', 'type': 'DRUG', 'armGroupLabels': ['Normovolemic group (keeping SVV<10% in supine; <15% in prone)', 'Restricitve group (keeping SVV < 18% in supine; <23% in prone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wu Chun-Yu', 'role': 'CONTACT', 'email': 'longersolo@gmail.com', 'phone': '+886-972653376'}, {'name': 'Chun-Yu Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chia-Chen Liu', 'role': 'CONTACT', 'email': 'a0918994038@yahoo.com.tw', 'phone': '+886-2-23123456', 'phoneExt': '65521'}], 'overallOfficials': [{'name': 'Chun-Yu Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital Anesthesiology Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}