NCT00933751

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

April 5, 2011

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

July 5, 2009

Last Update Submit

April 4, 2011

Conditions

Abdominal Surgery

Keywords

central venous oxygen saturationoxygen transportphysiologic monitoringtissue oxygenationPatients before high risk abdominal surgery

Study Arms (1)

Patients before emergent major abdominal surgery

Device: Central vein catheterization

Interventions

Central vein catheterizationDEVICE

Blood samplings from IVC catheter

Patients before emergent major abdominal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients before emergent high risk abdominal surgery

You may qualify if:

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

You may not qualify if:

  • Age \< 18
  • Pregnancy
  • Major coagulopathy
  • Permanent pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh MC

Beer-Yaakov, 70300, Israel

Location

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

Zoya Haitov, MD

CONTACT

089778080ZoyaC@asaf.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 5, 2009

First Posted

July 7, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Last Updated

April 5, 2011

Record last verified: 2009-07

Locations

IL(1)