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

This study is not yet open for participant recruitment.

Verified by Assaf-Harofeh Medical Center, July 2009

First Received: July 5, 2009 Last Updated: July 6, 2009 History of Changes

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00933751

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:	Case-Only, 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:

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933751

Contacts

Contact: Zoya Haitov, MD

089778080

ZoyaC@asaf.health.gov.il

Locations

Israel
Assaf-Harofeh MC
Beer-Yaakov, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

No publications provided

Responsible Party:	Zoya Haitov MD ( Changes of the oxygen saturation in the IVC during and after major abdominal surgery and relationship to the outcome )
Study ID Numbers:	100/09
Study First Received:	July 5, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933751 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

central venous oxygen saturation
oxygen transport
physiologic monitoring
tissue oxygenation
Patients before high risk abdominal surgery

Study placed in the following topic categories:

Kava

ClinicalTrials.gov processed this record on September 10, 2009