Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-04-17 @ 9:07 PM
Study NCT ID:
NCT03093766
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sodium balance', 'timeFrame': 'During ICU-admission', 'description': 'Differences in sodium balances between patients who do and do not develop IAH'}, {'measure': 'Fluid balance', 'timeFrame': 'During ICU-admission', 'description': 'Differences in fluid balances between patients who do and do not develop IAH'}], 'secondaryOutcomes': [{'measure': 'Kidney function', 'timeFrame': 'During ICU-admission', 'description': 'Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH'}, {'measure': 'Inflammation', 'timeFrame': 'During ICU-admission', 'description': 'Differences in inflammation (CRP, infections) between patients who do and do not develop IAH'}, {'measure': 'Nutritional state', 'timeFrame': 'During ICU-admission', 'description': 'Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aetiology'], 'conditions': ['ICU-acquired Hypernatremia']}, 'referencesModule': {'references': [{'pmid': '23336363', 'type': 'BACKGROUND', 'citation': "Darmon M, Diconne E, Souweine B, Ruckly S, Adrie C, Azoulay E, Clec'h C, Garrouste-Orgeas M, Schwebel C, Goldgran-Toledano D, Khallel H, Dumenil AS, Jamali S, Cheval C, Allaouchiche B, Zeni F, Timsit JF. Prognostic consequences of borderline dysnatremia: pay attention to minimal serum sodium change. Crit Care. 2013 Jan 21;17(1):R12. doi: 10.1186/cc11937."}, {'pmid': '27703807', 'type': 'BACKGROUND', 'citation': 'van IJzendoorn MC, Buter H, Kingma WP, Navis GJ, Boerma EC. The Development of Intensive Care Unit Acquired Hypernatremia Is Not Explained by Sodium Overload or Water Deficit: A Retrospective Cohort Study on Water Balance and Sodium Handling. Crit Care Res Pract. 2016;2016:9571583. doi: 10.1155/2016/9571583. Epub 2016 Sep 14.'}, {'pmid': '22404059', 'type': 'BACKGROUND', 'citation': 'Bihari S, Ou J, Holt AW, Bersten AD. Inadvertent sodium loading in critically ill patients. Crit Care Resusc. 2012 Mar;14(1):33-7.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to find differences between patients who do and do not develop ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be performed. Also a couple of other factors that possibly contribute to the development of IAH and/or could give clues about the mechanisms in the development of IAH will be investigated.', 'detailedDescription': "ICU-acquired hypernatremia (IAH) is common in critically ill patients, but it's aetiology is still not fully understood. Sodium overload and inadequate fluid administration are generally considered important factors, but a previous retrospective study did not reveal differences in sodium or fluid balances between patients who did and did not develop IAH. Because this was retrospective these balances will be prospectively studied in this study to be more sure about the importances of these balances in the development of IAH. Previous studies indicated that (a lot) more factors contribute to the development of IAH. In this study these factors will be investigated, hoping to find differences between patients who do and do not develop IAH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All unplanned ICU-admissions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Predicted duration of ICU-admission \\>48 hours\n\nExclusion Criteria:\n\n* Renal replacement therapy\n* Reason for admission necessitates actively elevation of serum sodium concentration\n* Electrolyte disturbance as reason for admission\n* ICU re-admission within 30 days\n* Referral from another ICU\n* Serum sodium concentration on admission 143mmol/l or above'}, 'identificationModule': {'nctId': 'NCT03093766', 'acronym': 'BIAS', 'briefTitle': 'Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Balance Study on ICU-acquired Hypernatremia and Sodium Handling', 'orgStudyIdInfo': {'id': 'ZRTPO 996'}}, 'contactsLocationsModule': {'locations': [{'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}], 'overallOfficials': [{'name': 'Christiaan Boerma', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'medical center leeuwarden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Collected data will be available through an online portal / storage website as soon as the manuscript was published. From that moment data can be obtained after a request via the online portal / storage website.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Groningen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}