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NCT00739089 Clinical Trial

Presep and Vascath Interaction Study

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00739089
Other study ID # IRB00004073
Secondary ID
Status Withdrawn
Phase N/A
First received August 20, 2008
Last updated November 6, 2017
Start date August 2008
Est. completion date December 2009

Study information
Verified date January 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary change in SvO2 before and afer initiation of dialysis via a vascath
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