A Study to Evaluate the Effectivenessof Induced Diuresis with Matched Hydration Therapy Compared to Standard Overnight Hydration in thePrevention of Contrast Induced Nephropathy - MYTHOS

• Conditions: Patients with moderate to severe renal failure candidates to angiographic procedures at high risk for CIN; MedDRA version: 9.1Level: LLTClassification code 10009119Term: Chronic renal failure

• Registration Number: EUCTR2008-001200-23-IT
• Lead Sponsor: FONDAZIONE MONZINO CENTRO CARDIOLOGICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or non-pregnant female with an age ≥18 years and ≤ 85 years.
2. Scheduled to undergo a non-emergent catheterization procedure with anticipated use of ≥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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified