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Presep and Vascath Interaction Study

This study has been terminated.
(Study stopped due to a lack of enrollment.)
Sponsor:
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT00739089
First received: August 20, 2008
Last updated: January 13, 2010
Last verified: February 2009
History of Changes
  Purpose

This is a prospective, observational study to compare presep(tm) catheter central vein mixed venous oxygen saturation before and after dialysis is initiated via the vascath(tm) central venous dialysis catheter to evaluate device interaction.


Condition
Hemodynamics
Renal Dialysis
Sepsis
Shock

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Pilot Study to Compare the Interaction Between Central Venous Mixed Venous Oxygen Saturation Catheters and Central Venous Hemodialysis Catheters

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • change in SvO2 [ Time Frame: before and afer initiation of dialysis via a vascath ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

The central venous oxygen saturation catheter measurement may be influenced by close approximation to the tip of the central venous hemodialysis catheter when hemodialysis is ongoing.

  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

medical intensive care unit (MICU) patients in an academic tertiary care referral medical center.

Criteria

Inclusion Criteria:

  • Admitted to the MICU
  • PreSep venous oxygen saturation central venous catheter already in place
  • VasCath central venous dialysis catheter already in place
  • Planned hemodialysis

Exclusion Criteria:

  • Patient unable to undergo hemodialysis
  • Contraindication for PreSep or VasCath catheters
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739089

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Arjun B Chatterjee, MD, MS Wake Forest University
  More Information

Publications:

Responsible Party: Arjun Chatterjee, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00739089     History of Changes
Other Study ID Numbers: IRB00004073
Study First Received: August 20, 2008
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
hemodynamics
oxygen
renal dialysis
shock
 sepsis
hypotension
lactic acidosis

Additional relevant MeSH terms:
Sepsis
Shock
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013