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Presep and Vascath Interaction Study

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ClinicalTrials.gov Identifier: NCT00739089
Recruitment Status : Withdrawn (Study stopped due to a lack of enrollment.)
First Posted : August 21, 2008
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease
Hemodynamics Renal Dialysis Sepsis Shock

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 Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources




Primary Outcome Measures :
  1. change in SvO2 [ Time Frame: before and afer initiation of dialysis via a vascath ]


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
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

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): NCT00739089


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

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00739089     History of Changes
Other Study ID Numbers: IRB00004073
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified data would have been shared with any other investigator with a local IRB approved protocol to evaluate de-identified patient data

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

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