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Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933751
First Posted: July 7, 2009
Last Update Posted: April 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
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.

Condition Intervention
Abdominal Surgery Device: Central vein catheterization

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients before emergent major abdominal surgery Device: Central vein catheterization
Blood samplings from IVC catheter

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients before emergent high risk abdominal surgery
Criteria

Inclusion Criteria:

  • All consecutive patients presenting for emergency surgery due to acute abdomen pain
  • Older than 18 years old
  • Not pregnant

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Major coagulopathy
  • Permanent pacemaker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933751


Contacts
Contact: Zoya Haitov, MD 089778080 ZoyaC@asaf.health.gov.il

Locations
Israel
Assaf-Harofeh MC Not yet recruiting
Beer-Yaakov, Israel, 70300
Contact: Zoya Haitov, MD    089778080    zoyac@asaf.health.gov.il   
Principal Investigator: Zoya Haitov, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Responsible Party: Changes of the oxygen saturation in the IVC during and after major abdominal surgery and relationship to the outcome, Zoya Haitov MD
ClinicalTrials.gov Identifier: NCT00933751     History of Changes
Other Study ID Numbers: 100/09
First Submitted: July 5, 2009
First Posted: July 7, 2009
Last Update Posted: April 5, 2011
Last Verified: July 2009

Keywords provided by Assaf-Harofeh Medical Center:
central venous oxygen saturation
oxygen transport
physiologic monitoring
tissue oxygenation
Patients before high risk abdominal surgery