Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-28 @ 12:09 AM
Study NCT ID:
NCT01360333
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2011-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Fluid Volume Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in hydration', 'timeFrame': '2.5 hours', 'description': 'volume kinetics: calculation from hemoglobin variations'}], 'secondaryOutcomes': [{'measure': 'fluid kinetic effects of oral carbohydrates', 'timeFrame': '2.5 hours', 'description': 'Electrolytes and blod glucose will be measured to se how much these are affected by the glucose upptake.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dehydration', 'Hydration'], 'conditions': ['Dehydration', 'Hydration']}, 'referencesModule': {'references': [{'pmid': '33957864', 'type': 'DERIVED', 'citation': 'Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.'}, {'pmid': '27471593', 'type': 'DERIVED', 'citation': 'Zdolsek J, Metander A, Hahn R. Volume kinetic evaluation of fluid turnover after oral intake of tap water, lemonade and saline in volunteers. BMC Sports Sci Med Rehabil. 2016 Jul 28;8:22. doi: 10.1186/s13102-016-0045-x. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': "When subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic.\n\nIn medical care it is common to give infusions. However it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. Moreover it is more simple to provide energy the natural way.\n\nWhich fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel.\n\nThe provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts).\n\nIn this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition.\n\nThe three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.", 'detailedDescription': 'The healthy volunteer starts the study by voiding. Then he/she lies down for 30 minutes. A blood sample is drawn and thereafter the healthy volunteer ingests one of the three fluids. Blood samples are drawn 10 times during the following two hours. Finally the healthy volunteer is asked to void and the voided urine is measured. The hemoglobin concentrations are used to calculate the blood volume expansion with volume kinetic methods.\n\nThe process is repeated another two times with the two remaining fluids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteer\n* 18 to 50 years old\n\nExclusion Criteria:\n\n* medication\n* any chronical disease'}, 'identificationModule': {'nctId': 'NCT01360333', 'acronym': 'OFVEX', 'briefTitle': 'Oral Fluid Volume Expansion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Oral Fluid: Absorption and Expansion of the Blood Volume', 'orgStudyIdInfo': {'id': 'OFVEX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tap water, sodium chloride, carbohydrate rich fluid', 'interventionNames': ['Other: tap water, sodium chloride, carbohydrate rich fluid']}], 'interventions': [{'name': 'tap water, sodium chloride, carbohydrate rich fluid', 'type': 'OTHER', 'description': 'Ingestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid.', 'armGroupLabels': ['Tap water, sodium chloride, carbohydrate rich fluid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Intensive Care Unit, University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Joachim Zdolsek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Linköping, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Joachim Zdolsek', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}