Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy (CIN) Prevention

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being proposed with the objective to assess the potential benefits of induced diuresis by furosemide with matched hydration therapy compared to standard hydration in the prevention of contrast-induced nephropathy (CIN). It is expected that matched hydration will prove to be as effective as hydration alone, will avoid an overnight stay prior to the procedure, and thus will prove to be a less costly and more clinically manageable solution to the prevention of CIN.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Cardiologico Monzino
• Treatments: Furosemide; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male or non-pregnant female equal or greater than the age of 18 years old.

2. Scheduled to undergo a non-emergent catheterization procedure with anticipated to use ≥80 ml contrast media. Additional other procedure (e.g., left ventriculography, imaging of grafts, stenting, etc.) are allowable other than those listed below as exclusion criteria #1.

3. Subject is clinically stable for >24hrs defined as Killip Class 1

4. Baseline Renal Function eGFR < 60ml/min, by MDRD (Modification of Diet in Renal Disease) calculator.

5. Patient has agreed to all follow-up testing.

Exclusion Criteria:

1. Catheterization procedure requiring a direct renal injection of contrast or an injection into the descending aorta proximal to the renal arteries.

2. Requires emergent catheterization or primary percutaneous intervention.

3. Subject is anuric, has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month.

4. Known inability to place a Foley catheter

5. Currently has a known electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.

6. Has received intravenous contrast within 10 days of procedure or has a planned procedure using contrast within 72 hours following the procedure.

7. Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.

8. Currently receiving or expected to receive Mannitol or Lithium therapy

9. Planned addition, discontinuation or dose adjustment of the trimethoprim, cimetidine, metaclopramide and/or the use of non-steroidal anti-inflammatory drugs within 48 hours of the procedure.

10. Subject has a known hypersensitivity to furosemide.

11. Subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.

12. If female, subject is pregnant or breastfeeding.

13. Subject is unable to provide informed consent.