RenalGuard System and Contrast Media (REMEDIALII)
Chronic Kidney Disease
About this trial
This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Contrast media, Kidney, Complication
Eligibility Criteria
Inclusion Criteria:
- Age >=18 years
- Chronic kidney disease (estimated glomerular filtration rate <=30 ml/min/1.72 m2) and/or
- Risk score for contrast nephropathy ≥11 (according to the Mehran score; J Am Coll Cardiol 2004; 44: 1393-1399)
Exclusion Criteria:
- Pregnancy
- Heart failure (NYHA functional class III-IV)
- Acute pulmonary edema
- Acute myocardial infarction
- Recent (<=2 days) contrast media exposure
- Patients enrolled in concomitant studies
- Administration of theophylline, dopamine, mannitol and fenoldopam.
- End-stage CKD (patients on chronic dialysis)
- Systemic hypotension (systolic blood pressure < 100 mg/dl).
- Multiple myeloma
Sites / Locations
- Unversity of Ferrara, Department of Cardiology
- IRCCS Multimedica
- Unversity School of Medicine of Modena, Deparment of Cardiology
- Clinica Mediterranea
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Systemic alone therapy group
RenalGuard System group
Systemic alone therapy group will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial i.v. bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.