Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Ramipril; Valsartan

Criteria

Inclusion Criteria:

• Age 18 years or older

• On thrice-weekly chronic hemodialysis for at least 6 months

• Clinically stable, adequately dialyzed (single-pool Kt/V> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

Exclusion Criteria:

• Body mass index > 35 mg/kg

• History of functional transplant less than 6 months prior to study

• Use of anti-inflammatory medications other than aspirin < 325 mg/d

• History of active connective tissue disease

• History of acute infectious disease within one month prior to study

• AIDS (HIV seropositivity is not an exclusion criteria)

• History of myocardial infarction or cerebrovascular event within 3 months

• Advanced liver disease

• Gastrointestinal dysfunction requiring parental nutrition

• Active malignancy excluding basal cell carcinoma of the skin

• History of ACE inhibitor-associated cough or angioedema

• Ejection fraction less than 40%

• Inability to discontinue ACE inhibitor or ARB

• Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)

• Anticipated live donor kidney transplant

• Use of vitamin E >60 IU/d or vitamin C >500 mg/d

• Pregnancy, breast-feeding or child-bearing potential

• History of poor adherence to hemodialysis or medical regimen

• Inability to provide consent