The Effect of Oxygen on Healing an Artery From the "Injury" of Surgery

NCT00863603 | Terminated

• 2 other identifiers: 0010M69621R01HL076316
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

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 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.

Conditions

End Stage Renal Disease

Keywords

Supplemental oxygen; Intimal hyperplasia; Graft patency

Outcome Measures

Primary Outcomes (1)

• The effect of supplemental oxygen on intimal thickness at the site of a hemodialysis access graft

  Assessing intimal thickness in the first 2 yrs after graft placement

Secondary Outcomes (1)

• Compare graft patency in oxygen supplemented vs. non oxygen supplemented group

  Assessing graft patency in the first two years after graft placement

Study Arms (2)

1

NO INTERVENTION

No exposure to supplemental oxygen

Oxygen, treatment, supplement

OTHER

6 weeks of supplemental oxygen delivered by nasal cannula post hemodialysis graft placement

Other: oxygen

Interventions

oxygen OTHER

5 Liter/minute by nasal cannula for 6 wks

Oxygen, treatment, supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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) -

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (3)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55401, United States

Location

Veterans Affairs Medical Center

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota, Division of Vascular Surgery

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (13)

• Tretinyak AS, Lee ES, Uema KM, d'Audiffret AC, Caldwell MP, Santilli SM. Supplemental oxygen reduces intimal hyperplasia after intraarterial stenting in the rabbit. J Vasc Surg. 2002 May;35(5):982-7. doi: 10.1067/mva.2002.123090.

  PMID: 12021715 BACKGROUND

• Santilli SM, Wernsing SE, Lee ES. The effect of supplemental oxygen on the transarterial wall oxygen gradients at a prosthetic vascular graft to artery anastomosis in the rabbit. Ann Vasc Surg. 2001 Jul;15(4):435-42. doi: 10.1007/s100160010119.

  PMID: 11525533 BACKGROUND

• Lee ES, Caldwell MP, Tretinyak AS, Santilli SM. Supplemental oxygen controls cellular proliferation and anastomotic intimal hyperplasia at a vascular graft-to-artery anastomosis in the rabbit. J Vasc Surg. 2001 Mar;33(3):608-13. doi: 10.1067/mva.2001.113495.

  PMID: 11241134 BACKGROUND

• Santilli SM, Tretinyak AS, Lee ES. Transarterial wall oxygen gradients at the deployment site of an intra-arterial stent in the rabbit. Am J Physiol Heart Circ Physiol. 2000 Oct;279(4):H1518-25. doi: 10.1152/ajpheart.2000.279.4.H1518.

  PMID: 11009436 BACKGROUND

• Santilli SM, Wernsing SE, Lee ES. Transarterial wall oxygen gradients at a prosthetic vascular graft to artery anastomosis in the rabbit. J Vasc Surg. 2000 Jun;31(6):1229-39. doi: 10.1067/mva.2000.104590.

  PMID: 10842160 BACKGROUND

• Lee ES, Bauer GE, Caldwell MP, Santilli SM. Association of artery wall hypoxia and cellular proliferation at a vascular anastomosis. J Surg Res. 2000 Jun 1;91(1):32-7. doi: 10.1006/jsre.2000.5891.

  PMID: 10816346 BACKGROUND

• Santilli SM, Kronson J, Payne WD. The effect of hypercholesterolemia on the rabbit transarterial wall oxygen gradient. Ann Vasc Surg. 1998 Sep;12(5):418-23. doi: 10.1007/s100169900178.

  PMID: 9732418 BACKGROUND

• Santilli SM, Kronson JW, Payne WD. Cigarette smoking alters the rabbit transarterial wall oxygen gradient. Ann Vasc Surg. 1998 Mar;12(2):174-81. doi: 10.1007/s100169900137.

  PMID: 9514238 BACKGROUND

• Santilli SM, Stevens RB, Anderson JG, Caldwell MD. The effect of aging on the transarterial wall oxygen gradient. Ann Vasc Surg. 1995 Mar;9(2):146-51. doi: 10.1007/BF02139656.

  PMID: 7786699 BACKGROUND

• Santilli SM, Stevens RB, Anderson JG, Payne WD, Caldwell MD. Transarterial wall oxygen gradients at the dog carotid bifurcation. Am J Physiol. 1995 Jan;268(1 Pt 2):H155-61. doi: 10.1152/ajpheart.1995.268.1.H155.

  PMID: 7840259 BACKGROUND

• Santilli SM, Fiegel VD, Knighton DR. Alloxan diabetes alters the rabbit transarterial wall oxygen gradient. J Vasc Surg. 1993 Aug;18(2):227-33.

  PMID: 8350431 BACKGROUND

• Santilli SM, Fiegel VD, Knighton DR. Changes in the aortic wall oxygen tensions of hypertensive rabbits. Hypertension and aortic wall oxygen. Hypertension. 1992 Jan;19(1):33-9. doi: 10.1161/01.hyp.19.1.33.

  PMID: 1730436 BACKGROUND

• Santilli SM, Fiegel VD, Aldridge DE, Knighton DR. Rabbit aortic endothelial cell hypoxia induces secretion of transforming growth factor beta and augments macrophage adhesion in vitro. Ann Vasc Surg. 1991 Sep;5(5):429-38. doi: 10.1007/BF02133047.

  PMID: 1958457 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Steven M Santilli, MD, PhD, MBA

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: August 1, 2009
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

US (3)