The Effect of Oxygen on Healing an Artery From the "Injury" of Surgery
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|ClinicalTrials.gov Identifier: NCT00863603|
Recruitment Status : Terminated (Clinical changes: graft to fistula first; enrollment of 46/132 planned. NIH approved animal model: supplemental oxygen/AV fistula.)
First Posted : March 18, 2009
Last Update Posted : May 25, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Other: oxygen||Not Applicable|
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 required at 2 sites (proximal and distal anastomoses) for every synthetic bypass graft. It is estimated that 50% of vascular bypass failures are due to anastomotic intimal hyperplasia (AIH). Intimal thickening of the artery wall is a normal response to healing at an anastomosis. Progression of intimal thickening leads to a pathological, hyperplastic, occlusive lesion - AIH, which in turn results in myocardial infarction, stroke, limb loss, death, graft failure, repeat operative procedures, and increased medical costs.
Our laboratory demonstrated in a rabbit model of AIH that: 1) there is a significant decrease in the delivery of oxygen to the peri-anastomotic artery wall following creation of a prosthetic vascular graft to artery anastomosis, 2) the oxygen gradient across the artery wall in the area of a prosthetic vascular graft anastomosis normalizes over a period of 6 weeks as healing occurs, 3) the gradient can be normalized immediately following an anastomosis by the administration of supplemental oxygen, and 4) the amount of AIH and smooth muscle cell proliferation can be reduced by immediately administering supplemental oxygen following creation of the anastomosis.
The long-range goal of our program is to understand the role of oxygen in blood vessel wall pathology. The specific objective of this project, which is the next step in the pursuit of our long-range program goal, is to determine if supplemental oxygen can inhibit AIH in a human graft model.
METHODS: Following review of inclusion and exclusion criteria suitable patients undergo surgical placement of a graft for hemodialysis. Following surgery, patients randomized to oxygen will breathe 5L supplemental oxygen during waking hours for 42 days. Periodic ultrasounds will be taken to assess graft function and patency and to measure intimal thickness. Patients will be followed for two years or until their graft fails.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Artery Wall Hypoxia and Intimal Hyperplasia|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||August 2009|
No Intervention: 1
No exposure to supplemental oxygen
Oxygen, treatment, supplement
6 weeks of supplemental oxygen delivered by nasal cannula post hemodialysis graft placement
5 Liter/minute by nasal cannula for 6 wks
- The effect of supplemental oxygen on intimal thickness at the site of a hemodialysis access graft [ Time Frame: Assessing intimal thickness in the first 2 yrs after graft placement ]
- Compare graft patency in oxygen supplemented vs. non oxygen supplemented group [ Time Frame: Assessing graft patency in the first two years after graft placement ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863603
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55401|
|Veterans Affairs Medical Center|
|Minneapolis, Minnesota, United States, 55417|
|University of Minnesota, Division of Vascular Surgery|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Steven M Santilli, MD, PhD, MBA||University of Minnesota|