Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02172092
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2014-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Kinetics in Patients With Diabetic Ketoacidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2014-06-22', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extracellular volume', 'timeFrame': '120 minutes', 'description': 'Masse balance as well as dilution af Sodium and Chloride are used to calculate extracellular volume during an infusion of SodiumChloride. Urine Sodium and Chloride are also measured to register and correct the mass balance.'}], 'secondaryOutcomes': [{'measure': 'Distribution of strong and weak acids', 'timeFrame': '12 hours', 'description': 'Blood gases are followed. With the Stuart/(Loob) concept it is determined to what degree ketones, lactate or electrolyte shifts influence the acidosis of the blood.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Ketoacidosis', 'fluid shift'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '36038699', 'type': 'DERIVED', 'citation': 'Svensson R, Hahn RG, Zdolsek JH, Bahlmann H. Plasma volume expansion reveals hidden metabolic acidosis in patients with diabetic ketoacidosis. Intensive Care Med Exp. 2022 Dec;10(1):36. doi: 10.1186/s40635-022-00464-5. Epub 2022 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis.\n\nIn the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.', 'detailedDescription': 'Patients treated for diabetic ketoacidosis receive 1000 ml of Sodium Chloride during the first 30 minutes of treatment.\n\nBefore, during and after this infusion regular blood samples(and urine) are collected (0, 10, 20, 30, 35, 40, 45, 50, 60, 120, 180 and 300 minutes after infusion start).\n\nB-Hemoglobin, P-Albumine, B-Glucose, P-Sodium, P-Potassium. P-Chlorides, U-Sodium, U-Chloride and U-Glucose. Hourly volume of urine is measured.\n\nThe 30 minute infusion can be used to calculate the urine extracellular volume. Thereafter during infusion of Ringers acetate changes in electrolytes in blood as well as urine volume and in the urine excreted electrolytes can be used to calculate the fluid shifts between the different fluid compartments.\n\nEventually 8 to 12 hours later a second infusion of SodiumChloride is as a control performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.\n\nExclusion Criteria:\n\n* unconscious patient'}, 'identificationModule': {'nctId': 'NCT02172092', 'acronym': 'FDKA', 'briefTitle': 'Fluid Kinetics in Patients With Diabetic Ketoacidosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Fluid Kinetics in Patients With Diabetic Ketoacidosis', 'orgStudyIdInfo': {'id': 'FDKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketoacidosis', 'description': 'Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping.', 'interventionNames': ['Drug: SodiumChloride']}], 'interventions': [{'name': 'SodiumChloride', 'type': 'DRUG', 'description': 'Infusion of SodiumChloride, blood samples to calculate extracellular volume.', 'armGroupLabels': ['Ketoacidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60379', 'city': 'Norrköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}], 'overallOfficials': [{'name': 'Robert Hahn, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vrinnevi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor', 'investigatorFullName': 'Joachim Zdolsek', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}