Presep and Vascath Interaction Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

February 13, 2009

Start Date ^†

August 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00739089 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Presep and Vascath Interaction Study

Official Title ^†

A Pilot Study to Compare the Interaction Between Central Venous Mixed Venous Oxygen Saturation Catheters and Central Venous Hemodialysis Catheters

Brief Summary

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.

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Hemodynamics
Renal Dialysis
Sepsis
Shock

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Arjun B Chatterjee, MD, MS

336.716.4649

achatter@wfubmc.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00739089

Responsible Party

Arjun Chatterjee, Wake Forest University Health Sciences

Secondary IDs ^††

Study Sponsor ^†

Wake Forest University

Collaborators ^††

Investigators ^†

Principal Investigator:

Arjun B Chatterjee, MD, MS

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.