RenalGuard System and Contrast Media

PHASE3CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2011

Conditions
Chronic Kidney Disease
Interventions
DEVICE

RenalGuard system

The RenalGuard™ System (PLC Medical Systems, Inc.) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard Therapy. The RenalGuard Therapy is based on the concept demonstrated by clinical data that high urine output is beneficial to patients with impaired baseline renal function who receive intravascular iodinated contrast medio (CM). The RenalGuard System seems to be ideal for the prevention of CI-AKI, by allowing an optimal urine flow rate \>300 ml/h. It is known that excessive diuresis can cause dehydration which increases the risk to the kidneys from CM. The RenalGuard System should allow the patient to achieve high urine output safely by maintaining the intravascular blood volume and avoiding the risk of over-or-under-hydration.

DRUG

Systemic alone therapy

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. The initial intravenous 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)

Trial Locations (4)

80121

Clinica Mediterranea, Naples

Unknown

Unversity of Ferrara, Department of Cardiology, Ferrara

IRCCS Multimedica, Milan

Unversity School of Medicine of Modena, Deparment of Cardiology, Modena

Sponsors
All Listed Sponsors
lead

Clinica Mediterranea

OTHER

NCT01098032 - RenalGuard System and Contrast Media | Biotech Hunter | Biotech Hunter