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

FONDAZIONE MONZINO CENTRO CARDIOLOGICO0 个研究点开始时间: 2008年5月28日最近更新: 2012年3月19日

试验速览

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•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

•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
•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.

发起方

FONDAZIONE MONZINO CENTRO CARDIOLOGICO