Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03429127
Status:
UNKNOWN
Last Update Posted:
2019-04-18
First Post:
2018-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020785', 'term': 'Central Nervous System Vascular Malformations'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'C012499', 'term': 'Plasma-lyte 148'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-02-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2018-02-03', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma osmolality', 'timeFrame': 'Immediately after operation', 'description': 'Whether the applied fluids affect plasma osmolality'}], 'primaryOutcomes': [{'measure': 'Changes in acid base pH status', 'timeFrame': 'During operation and immediately after operation', 'description': 'Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid'}], 'secondaryOutcomes': [{'measure': 'Changes in electrolytes (sodium and chloride)', 'timeFrame': 'During operation and immediately after operation', 'description': 'Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balanced fluids, neurosurgery, plasma osmolality'], 'conditions': ['Benign Neoplasms', 'Vascular Malformations, Brain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.', 'detailedDescription': 'Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with brain tumor, meningeomas and vascular malformation.\n\nExclusion Criteria:\n\n* Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease'}, 'identificationModule': {'nctId': 'NCT03429127', 'briefTitle': 'Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Hospital Centre Zagreb'}, 'officialTitle': 'Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery', 'orgStudyIdInfo': {'id': '02/21 AG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal saline fluid group', 'description': 'The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation.', 'interventionNames': ['Other: Normal saline']}, {'label': 'Balanced fluid group', 'description': 'The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation.', 'interventionNames': ['Other: Balanced fluid']}], 'interventions': [{'name': 'Normal saline', 'type': 'OTHER', 'otherNames': ['0,9 % sodium chloride'], 'description': 'Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation', 'armGroupLabels': ['Normal saline fluid group']}, {'name': 'Balanced fluid', 'type': 'OTHER', 'otherNames': ['Plasma-Lyte 148'], 'description': 'Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation', 'armGroupLabels': ['Balanced fluid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Natasa Kovac, M.D.', 'role': 'CONTACT', 'email': 'natasakovac787@gmail.com', 'phone': '+38598296686'}, {'name': 'Inga Mladic Batinica, M.D.', 'role': 'CONTACT', 'email': 'ingamblue@gmail.com', 'phone': '+385917811015'}], 'facility': 'UHC Zgagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Natasa Kovac, M.D.', 'role': 'CONTACT', 'email': 'natasakovac787@gmail.com', 'phone': '+38598296686'}, {'name': 'Inga Mladic Batinica, M.D.', 'role': 'CONTACT', 'email': 'ingamblue@gmail.com', 'phone': '+385917811015'}], 'overallOfficials': [{'name': 'Natasa Kovac, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UHC Zagreb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Hospital Centre Zagreb', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sisters of Mercy University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist', 'investigatorFullName': 'Natasa Kovac', 'investigatorAffiliation': 'Clinical Hospital Centre Zagreb'}}}}