The Effect of Oxygen on Healing an Artery From the "Injury" of Surgery
Stopped early · Not applicable
Conditions studied: End Stage Renal Disease
In brief
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 see if dialysis access grafts will function longer for patients who receive additional oxygen by means of a nasal cannula for 42 days after placement of their graft. Patients will have periodic blood tests to measure oxygen levels in their blood. A series of ultrasound examinations of patient's dialysis grafts will be taken to ensure the graft is open and to measure the cellular proliferation (intimal hyperplasia) for comparison in those receiving extra oxygen and those with no oxygen.
Key facts
- Study ID
- NCT00863603
- Run by
- University of Minnesota
- People needed
- 46
- Starts
- 2005-01-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2012-05-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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) -
Where it is running
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
- Veterans Affairs Medical Center — Minneapolis, Minnesota, United States
- University of Minnesota, Division of Vascular Surgery — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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