Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-28 @ 3:39 AM
Study NCT ID:
NCT01650103
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys by Measuring Some Physiological Substances in Blood and Urines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2012-07-23', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of mixed oxygen saturation in central venous blood (ScvO2) and three urinary electrolytes (sodium, potassium, chloride)', 'timeFrame': 'During the stay of the patient in the operating room (in average 6 hours) and the eventual stay in the post-surgery intensive care unit (in average 1 day)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypovolemia', 'renal hypoperfusion', 'major surgery', 'sodium', 'potassium', 'chloride', 'ScvO2', 'hemodynamic indexes'], 'conditions': ['Hypovolemia', 'Renal Hypoperfusion']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify any existing relationship between mixed oxygen saturation (from central venous catheter) and urinary sodium, potassium, chloride in determining the volemic state and renal perfusion of patients undergoing major surgical interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing major surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* thoracic-abdominal major surgical operations\n* placing of a central venous catheter and urinary catheter\n* age 18-75\n* ASA class I-III\n\nExclusion Criteria:\n\n* age above 75 or under 18\n* ASA class IV\n* trauma, sepsis and/or heart-lung failure\n* liver transplantation\n* kidney transplantation\n* pre-existing renal failure\n* pregnant patients\n* patients unable to give their written consent'}, 'identificationModule': {'nctId': 'NCT01650103', 'briefTitle': 'Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys by Measuring Some Physiological Substances in Blood and Urines', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera di Padova'}, 'officialTitle': 'Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.', 'orgStudyIdInfo': {'id': '2660P'}}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'state': 'Padova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'role': 'CONTACT', 'phone': '+390498218285'}, {'role': 'CONTACT', 'phone': '+390498218286'}, {'name': 'Andrea Bortolato, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniele Bonvicini, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tommaso Tonetti, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paolo Feltracco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Andrea Bortolato, M.D.', 'role': 'CONTACT', 'email': 'freeandrea.b@libero.it', 'phone': '+393316169933'}, {'name': 'Paolo Feltracco, M.D.', 'role': 'CONTACT', 'email': 'paolofeltracco@inwind.it', 'phone': '+393493410225'}], 'overallOfficials': [{'name': 'Carlo Ori, Prof. M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Padova'}, {'name': 'Paolo Feltracco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera di Padova'}, {'name': 'Andrea Bortolato, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera di Padova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Paolo Feltracco', 'investigatorAffiliation': 'Azienda Ospedaliera di Padova'}}}}