Status:
TERMINATED
The Effect of Oxygen on Healing an Artery From the "Injury" of Surgery
Lead Sponsor:
University of Minnesota
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Many grafts placed for dialysis access fail which causes patients to undergo additional operations, decreases their quality of life, and increases health care costs. The purpose of this study is to se...
Detailed Description
Vascular bypass grafting is a commonly performed procedure in vascular and cardiovascular surgery and the preferred bypass grafts are autogenous vein. Creation of a vascular anastomosis (AVA) is requi...
Eligibility Criteria
Inclusion
- Age 18-80+/- referred and considered a candidate for a synthetic hemodialysis access graft.
- Baseline room air arterial blood concentration \>70 and arterial carbon dioxide concentration 45 mmHg. Pulmonary function tests \> 75% predicted values
- Currently undergoing dialysis
- No previous synthetic hemodialysis grafts placed in the same arm (fistula in ipsilateral arm permitted)
- Ability to use 5L/minute supplemental oxygen by nasal cannula
- Nonsmoker, able to avoid other situations which would constitute a risk for use of oxygen
- Medical condition with \> 1 year life expectancy
- Currently on no medications which would interfere with wound healing (i.e. steroids, chemotherapeutic agents)
- Not pregnant nor planning to become pregnant during study period
Exclusion
- Failure to meet inclusion criteria
- Failure to comply with study protocol for 3 consecutive days during the 6 wk oxygen/non-oxygen supplement period immediately following graft placement
- Medical condition developing during study period causing a significantly worsening pulmonary function requiring supplemental oxygen for \> 3 days
- Need to take medication during study period which would interfere with wound healing any time during the 6 week period immediately following graft placement or need to take chronic medications (\> 6 weeks) during the remainder of the study period.
- Patient desire to withdraw
- Failure of evidence of adequate increase in arterial blood oxygen concentration (pa02 \> 115 for oxygen supplemented and pa02 \> 55 mmHg for control obtained from arterial access port during dialysis run
- Failure to use supplemental oxygen (if in supplemental oxygen group) at least 18 hours per day (as recorded in journal) -
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00863603
Start Date
January 1 2005
End Date
August 1 2009
Last Update
May 25 2012
Active Locations (3)
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1
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55401
2
Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
3
University of Minnesota, Division of Vascular Surgery
Minneapolis, Minnesota, United States, 55455