Clinical trial NCT00739089: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemodynamics
Renal Dialysis
Sepsis
Shock
Keywords: hemodynamics
oxygen
renal dialysis
shock
sepsis
hypotension
lactic acidosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical intensive care unit (MICU) patients in an academic tertiary care referral medical center.

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.

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

Primary outcomes:
measure: change in SvO2
timeFrame: before and afer initiation of dialysis via a vascath
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Arjun B Chatterjee, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/0002-9343(84)90519-9.
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. doi: 10.1097/00003246-200107000-00015.
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. doi: 10.1378/chest.103.3.900.
citation: 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. doi: 10.1038/ki.1983.87. No abstract available.
citation: Quebbeman EJ, Maierhofer WJ, Piering WF. Mechanisms producing hypoxemia during hemodialysis. Crit Care Med. 1984 Apr;12(4):359-63. doi: 10.1097/00003246-198404000-00004.
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. doi: 10.1164/ajrccm.162.3.ncc400. No abstract available.