Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-03 @ 5:51 PM
Study NCT ID:
NCT00626756
Status:
UNKNOWN
Last Update Posted:
2008-02-29
First Post:
2008-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'lastUpdateSubmitDate': '2008-02-28', 'studyFirstSubmitDate': '2008-02-21', 'studyFirstSubmitQcDate': '2008-02-28', 'lastUpdatePostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive or negative fluid balance', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'effect of LiDCO monitoring on cumulative fluid balance', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fluid', 'Lidco technology', 'guided therapy', 'fluid management guided by Lidco technology'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '9361539', 'type': 'BACKGROUND', 'citation': 'Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.'}, {'pmid': '16155038', 'type': 'BACKGROUND', 'citation': 'Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005 Nov;95(5):634-42. doi: 10.1093/bja/aei223. Epub 2005 Sep 9.'}, {'pmid': '11869649', 'type': 'BACKGROUND', 'citation': 'Price J, Sear J, Venn R. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2002;(1):CD003004. doi: 10.1002/14651858.CD003004.'}, {'pmid': '14974001', 'type': 'BACKGROUND', 'citation': 'Price JD, Sear JW, Venn RM. Perioperative fluid volume optimization following proximal femoral fracture. Cochrane Database Syst Rev. 2004;(1):CD003004. doi: 10.1002/14651858.CD003004.pub2.'}, {'pmid': '12190747', 'type': 'BACKGROUND', 'citation': 'Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomised controlled trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002 Sep;57(9):845-9. doi: 10.1046/j.1365-2044.2002.02708.x.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Fluid management guided by LiDCO doesn´t increase cumulative fluid balance and shorten organ dysfunction compared to fluid management based on CVP and clinical judgment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\n* Needs for fluid chalange\n* Invasive ventilatory supportinvasive blood pressure monitoring\n* Lidco monitoring\n* Central venous catheter\n\nExclusion Criteria:\n\n* DNR\n* Need for CRRT\n* Head injury'}, 'identificationModule': {'nctId': 'NCT00626756', 'acronym': 'LIGA', 'briefTitle': 'Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ASQA a.s.'}, 'officialTitle': 'LIGA Trial-Lithium Dilution Method in Guiding Fluid Therapy in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'LigaStudy'}, 'secondaryIdInfos': [{'id': 'LIGA2008'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LI', 'description': 'arm controled by LIDCO technology', 'interventionNames': ['Device: LiDCO technology']}, {'type': 'NO_INTERVENTION', 'label': 'CA', 'description': 'standard approach'}], 'interventions': [{'name': 'LiDCO technology', 'type': 'DEVICE', 'description': 'non invasive monitoring of cardiac output', 'armGroupLabels': ['LI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '106 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Pavel Valek, MD', 'role': 'CONTACT', 'email': 'pavel.valek@asqa.cz', 'phone': '+420272761350'}, {'name': 'Vladimir Cerny, MD, PhD, FCCM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASQA a.s.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Vladimir Cerny, MD', 'role': 'CONTACT', 'email': 'cernyvla@fnhk.cz'}, {'name': 'Pavel Valek, MD', 'role': 'CONTACT', 'email': 'pavel.valek@asqa.cz', 'phone': '+420272761350'}], 'overallOfficials': [{'name': 'Vladimir Cerny, MD, PhD, FCCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hradec Kralove'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASQA a.s.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pavel Valek M.D.', 'oldOrganization': 'ASQA a.s.'}}}}