Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT03453320
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2018-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-25', 'studyFirstSubmitDate': '2018-02-24', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma volume', 'timeFrame': '6 hours', 'description': 'Albumin infusion expands the plasma volume and dilutes hemoglobin. The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.'}], 'secondaryOutcomes': [{'measure': 'Colloid osmotic pressure', 'timeFrame': '6 hours', 'description': 'Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma. Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure. This effect is measured.'}, {'measure': 'Fluid recruitment from tissues', 'timeFrame': '6 hours', 'description': 'The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured. The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edema Secondary']}, 'descriptionModule': {'briefSummary': 'Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.\n\nOne of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.\n\nIn this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.', 'detailedDescription': 'Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.\n\nPlasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.\n\nHealthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.\n\nAfter 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).\n\nDuring each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.\n\nUrinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Healthy, without allergies and with the age 18 years or above\n\nExclusion Criteria:\n\n* Heart failure\n* Signs of kidney injury/failure\n* Severe allergies\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03453320', 'acronym': '(RAV)', 'briefTitle': 'Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects', 'orgStudyIdInfo': {'id': 'RAV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid - Slow', 'description': 'Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.\n\nFirst time rapid (30 minutes), second time slow (120 minutes). Albumin solution', 'interventionNames': ['Drug: Albumin solution']}, {'type': 'EXPERIMENTAL', 'label': 'Slow - Rapid', 'description': 'Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between.\n\nFirst time rapid (120 minutes), second time slow (30 minutes). Albumin solution', 'interventionNames': ['Drug: Albumin solution']}], 'interventions': [{'name': 'Albumin solution', 'type': 'DRUG', 'description': 'Infusion rate and effects', 'armGroupLabels': ['Rapid - Slow', 'Slow - Rapid']}]}, '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,Assoc prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Linkoeping'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Assoc prof, consultant', 'investigatorFullName': 'Joachim Zdolsek', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}