Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00933751
Status:
UNKNOWN
Last Update Posted:
2011-04-05
First Post:
2009-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002405', 'term': 'Catheterization, Central Venous'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2011-04-04', 'studyFirstSubmitDate': '2009-07-05', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['central venous oxygen saturation', 'oxygen transport', 'physiologic monitoring', 'tissue oxygenation', 'Patients before high risk abdominal surgery'], 'conditions': ['Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'Tissue hypoxia is one of the most important factors leading to the development of multiorgan failure. Patients presenting for emergent major abdominal surgery might suffer from organ hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may improve the outcome. The investigators believe that hypoperfusion of the abdominal organs will cause a decrease of the saturation in the hepatic vein and in the IVC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients before emergent high risk abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients presenting for emergency surgery due to acute abdomen pain\n* Older than 18 years old\n* Not pregnant\n\nExclusion Criteria:\n\n* Age \\< 18\n* Pregnancy\n* Major coagulopathy\n* Permanent pacemaker'}, 'identificationModule': {'nctId': 'NCT00933751', 'briefTitle': 'Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome.', 'orgStudyIdInfo': {'id': '100/09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients before emergent major abdominal surgery', 'interventionNames': ['Device: Central vein catheterization']}], 'interventions': [{'name': 'Central vein catheterization', 'type': 'DEVICE', 'description': 'Blood samplings from IVC catheter', 'armGroupLabels': ['Patients before emergent major abdominal surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Beer-Yaakov', 'country': 'Israel', 'contacts': [{'name': 'Zoya Haitov, MD', 'role': 'CONTACT', 'email': 'zoyac@asaf.health.gov.il', 'phone': '089778080'}, {'name': 'Zoya Haitov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assaf-Harofeh MC'}], 'centralContacts': [{'name': 'Zoya Haitov, MD', 'role': 'CONTACT', 'email': 'ZoyaC@asaf.health.gov.il', 'phone': '089778080'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Changes of the oxygen saturation in the IVC during and after major abdominal surgery and relationship to the outcome', 'oldOrganization': 'Zoya Haitov MD'}}}}