Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Condition: End Stage Renal Failure on Dialysis; Complication of Hemodialysis
MeSH terms: Kidney Failure, Chronic
Intervention: Placebo; Ramipril; Valsartan
Intervention description: Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis; Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis; Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis
Intervention MeSH terms: Valsartan; Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemodialysis; oxidative stress; inflammation; kallikrein-kinin; angiotensin receptor blockade; angiotensin converting enzyme inhibition; RAAS; fibrinolysis; endothelial dysfunction

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.
    

Eligibility 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