Presep and Vascath Interaction Study
Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00739089
Collaborator
(none)
0
1
16
0
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
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
:
Aug 1, 2008
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Outcome Measures
Primary Outcome Measures
- change in SvO2 [before and afer initiation of dialysis via a vascath]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Quebbeman EJ, Maierhofer WJ, Piering WF. Mechanisms producing hypoxemia during hemodialysis. Crit Care Med. 1984 Apr;12(4):359-63.
- 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.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00739089
Other Study ID Numbers:
- IRB00004073
First Posted:
Aug 21, 2008
Last Update Posted:
Nov 8, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Wake Forest University Health Sciences
Additional relevant MeSH terms: