RenalGuard System and Contrast Media
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: RenalGuard system; Systemic alone therapy
Intervention description: The RenalGuard™ System (PLC Medical Systems, Inc.) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard Therapy. The RenalGuard Therapy is based on the concept demonstrated by clinical data that high urine output is beneficial to patients with impaired baseline renal function who receive intravascular iodinated contrast medio (CM). The RenalGuard System seems to be ideal for the prevention of CI-AKI, by allowing an optimal urine flow rate >300 ml/h. It is known that excessive diuresis can cause dehydration which increases the risk to the kidneys from CM. The RenalGuard System should allow the patient to achieve high urine output safely by maintaining the intravascular blood volume and avoiding the risk of over-or-under-hydration.; Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days)
Intervention MeSH terms: Acetylcysteine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Contrast media; Kidney; Complication

Summary:

      The purpose of the present study is to assess the role of the RenalGuard System as compared
      to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and
      very-high risk patients to prevent contrast-induced acute kidney injury contrast induced
      acute kidney injury (CI-AKI).

      Consecutive patients with chronic kidney disease, referred to our institutions for coronary
      and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of
      sodium bicarbonate plus NAC (Systemic alone therapy group; n > 133) and 2) RenalGuard System
      treatment (RenalGuard group; n > 133). All enrolled patients must have an estimated
      glomerular filtration rate <30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11).
      In all cases iodixanol (an iso-osmolar, non ionic contrast agent) will be administered. The
      primary end point is an increase of >=0.3 mg/dL in the creatinine concentration 48 hours
      after the procedure.

      This study will give important answers on how to prevent CI-AKI in high and very-high risk
      patients undergoing contrast media exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age >=18 years

          2. Chronic kidney disease (estimated glomerular filtration rate <=30 ml/min/1.72 m2)
             and/or

          3. Risk score for contrast nephropathy ≥11 (according to the Mehran score; J Am Coll
             Cardiol 2004; 44: 1393-1399)

        Exclusion Criteria:

          1. Pregnancy

          2. Heart failure (NYHA functional class III-IV)

          3. Acute pulmonary edema

          4. Acute myocardial infarction

          5. Recent (<=2 days) contrast media exposure

          6. Patients enrolled in concomitant studies

          7. Administration of theophylline, dopamine, mannitol and fenoldopam.

          8. End-stage CKD (patients on chronic dialysis)

          9. Systemic hypotension (systolic blood pressure < 100 mg/dl).

         10. Multiple myeloma