Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT00636857
Status:
UNKNOWN
Last Update Posted:
2013-06-12
First Post:
2008-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Hyponatremia - Are There Gender Differences?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055103', 'term': 'Hypodermoclysis'}], 'ancestors': [{'id': 'D055104', 'term': 'Infusions, Subcutaneous'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005440', 'term': 'Fluid Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2008-03-10', 'studyFirstSubmitQcDate': '2008-03-10', 'lastUpdatePostDateStruct': {'date': '2013-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change between preoperative and postoperative plasma sodium concentration', 'timeFrame': '24 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Water-Electrolyte Imbalance'], 'conditions': ['Hyponatremia']}, 'descriptionModule': {'briefSummary': 'The proposed study will focus on anesthesia and anesthesia-induced hypotension as a possible cause for postoperative fluid retention and hyponatremia, and investigate gender differences in this response.', 'detailedDescription': '30 healthy women and 30 healthy men, who are scheduled for surgery of the middle ear or parotic gland are included in the study. Within each gender group, the subjects are randomized to receive perioperative intravenous fluid regimes either based on body weight or lean body mass (LBM). The surgery lasts for at least 3 hours, the intervention period (fluid administration according to protocol) will last 10-12 hours, the study period will be 20-24 hours. Blood samples for analysis of plasma sodium, potassium, glucose and osmolality are collected preoperatively and the following morning together with analysis of urine produced during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Physical status I-II\n* Subjects scheduled for otorinolaryngoiatric surgery in general anesthesia of at least 3 hours duration\n\nExclusion Criteria:\n\n* BMI less than 18\n* BMI greater than 33\n* Diabetes mellitus requiring medication\n* Treatment with diuretics\n* ACE-inhibitors\n* Angiotensin II antagonists\n* Cortisone\n* Lithium\n* Diseases of the kidney\n* Females:\n\n * Pregnancy\n * Menopause\n * Endocrine dysfunction influencing menstruation'}, 'identificationModule': {'nctId': 'NCT00636857', 'briefTitle': 'Postoperative Hyponatremia - Are There Gender Differences?', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Postoperative Hyponatremia - Are There Gender Differences?', 'orgStudyIdInfo': {'id': 'NKOISR10003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Perioperative fluid management based on body weight', 'interventionNames': ['Procedure: Fluid administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Perioperative fluid management based on Lean Body Mass (LBM)', 'interventionNames': ['Procedure: Perioperative fluid management based on Lean Body Mass']}], 'interventions': [{'name': 'Fluid administration', 'type': 'PROCEDURE', 'otherNames': ['Fluid administration by body weight'], 'description': 'Preoperative: bolus of 10 ml/kg body weight. During operation: 5 ml/kg body weight/hr. Postoperative: 3 ml/kg body weight/hr', 'armGroupLabels': ['I']}, {'name': 'Perioperative fluid management based on Lean Body Mass', 'type': 'PROCEDURE', 'otherNames': ['Fluid administration by Lean Body Mass'], 'description': 'Preoperative: bolus of 12 ml/kg LBM. During operation: 6 ml/kg LBM/hr. Postoperative: 3.5 ml/kg LBM/hr', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anna Januszkiewics, M.D. Ph.D', 'role': 'CONTACT', 'email': 'anna.januszkiewics@karolinska.se', 'phone': '+ 46 8 58580998'}, {'name': 'Selma Najeeb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesia and Intensive Care, Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '39185', 'city': 'Kalmar', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Vibeke Moen, MD', 'role': 'CONTACT', 'email': 'vibekem@ltkalmar.se', 'phone': '+46 480 81200'}, {'name': 'Vibeke Moen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept of Anaesthesia and Intensive Care, Kalmar County Hospital', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'zip': '58185', 'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christina Eintrei, PhD', 'role': 'CONTACT', 'email': 'christina.eintrei@liu.se'}, {'name': 'Patrik Johansson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina Eintrei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anaesthesia and Operation', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '171 76', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Johan Ullman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dept. of Anesthesiology and Intensive Care, Karolinska University Hospital, Solna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75185', 'city': 'Uppsala', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Dept of Anaesthesia and Intensive Care, Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Johan Ullman, MD., PhD.', 'role': 'CONTACT', 'email': 'johan.ullman@karolinska.se', 'phone': '+46 8 51 77 00 00'}, {'name': 'Vibeke Moen, MD', 'role': 'CONTACT', 'email': 'vibekem@ltkalmar.se', 'phone': '+4648081200'}], 'overallOfficials': [{'name': 'Johan Ullman, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anesthesia and Intensive Care, Karolinska University Hospital, Stockholm,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Vibeke Moen', 'investigatorAffiliation': 'Karolinska Institutet'}}}}