Overview

RenalGuard System and Contrast Media

Status:
Completed

Trial end date:
2011-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Clinica Mediterranea

Treatments:

Acetylcysteine
Polystyrene sulfonic acid

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