Presep and Vascath Interaction Study - Full Text View

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00739089

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

MedlinePlus related topics: Dialysis Kidney Failure Sepsis

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2008

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

Contacts

Contact: Arjun B Chatterjee, MD, MS

336.716.4649

achatter@wfubmc.edu

Locations

United States, North Carolina
Wake Forest University Health Sciences	Recruiting
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:

Vaziri ND, Wilson A, Mukai D, Darwish R, Rutz A, Hyatt J, Moreno C. Dialysis hypoxemia. Role of dialyzer membrane and dialysate delivery system. Am J Med. 1984 Nov;77(5):828-33.

Jakob SM, Ruokonen E, Vuolteenaho O, Lampainen E, Takala J. Splanchnic perfusion during hemodialysis: evidence for marginal tissue perfusion. Crit Care Med. 2001 Jul;29(7):1393-8.

Krafft P, Steltzer H, Hiesmayr M, Klimscha W, Hammerle AF. Mixed venous oxygen saturation in critically ill septic shock patients. The role of defined events. Chest. 1993 Mar;103(3):900-6.

De Backer WA, Verpooten GA, Borgonjon DJ, Vermeire PA, Lins RR, De Broe ME. Hypoxemia during hemodialysis: effects of different membranes and dialysate compositions. Kidney Int. 1983 May;23(5):738-43. No abstract available.

Quebbeman EJ, Maierhofer WJ, Piering WF. Mechanisms producing hypoxemia during hemodialysis. Crit Care Med. 1984 Apr;12(4):359-63.

Murray P, Hall J. Renal replacement therapy for acute renal failure. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):777-81. No abstract available.

Responsible Party:	Wake Forest University Health Sciences ( Arjun Chatterjee )
Study ID Numbers:	IRB00004073
Study First Received:	August 20, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739089
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

hemodynamics
oxygen
renal dialysis
shock

sepsis
hypotension
lactic acidosis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Hypotension
Sepsis
Acidosis, Lactic

Shock
Acidosis
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009