Patients with moderate to severe renal failure candidates to angiographic procedures at high risk for CIN MedDRA version: 9.1 Level: LLT Classification code 10009119 Term: Chronic renal failure
Conditions
Interventions
Trade Name: LASIX*INIET 5F 2ML 20MG/2ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Furosemide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
FONDAZIONE MONZINO CENTRO CARDIOLOGICO
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to provide an assessment of the potential benefits of induced diuresis with matched hydration therapy compared to hydration in the prevention of CIN.;Secondary Objective: In addition, the effects of the therapy on patient safety will be determined by comparing heart rate, blood pressure, blood chemistry values and adverse events in the two treatment groups.;Primary end point(s): incidence of CIN (defined as a >0.5 mg/dl or >25% rise in serum creatinine within 72 hours post contrast administration) | — |
Countries
Italy
Outcome results
None listed