Clinical trial NCT01098032: RenalGuard System and Contrast Media
Official title: Renal Insufficiency Following Contrast Media Administration Trial II (Remedial II): The RenalGuard System in High-Risk Patients for Contrast-Induced Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Contrast media
Kidney
Complication
Lead sponsor: Clinica Mediterranea
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study is to assess the role of the RenalGuard System as compared to the optimal strategy (sodium bicarbonate infusion plus N-acetylcysteine (NAC)) in high and very-high risk patients to prevent contrast-induced acute kidney injury contrast induced acute kidney injury (CI-AKI).

Consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (Systemic alone therapy group; n \> 133) and 2) RenalGuard System treatment (RenalGuard group; n \> 133). All enrolled patients must have an estimated glomerular filtration rate \<30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥11). In all cases iodixanol (an iso-osmolar, non ionic contrast agent) will be administered. The primary end point is an increase of \>=0.3 mg/dL in the creatinine concentration 48 hours after the procedure.

This study will give important answers on how to prevent CI-AKI in high and very-high risk patients undergoing contrast media exposure.

Detailed description: The strategy of volume supplementation by sodium bicarbonate plus N-acetylcysteine (NAC) seems to be the optimal pharmacological approach in preventing contrast induced acute kidney injury (CI-AKI) in patients at medium-to-high risk. Whether this prophylactic strategy is effective in high and very-high risk patients is unknown. In this subset of patients the potential protective effects and therapeutic advantage of a local delivery of protective compounds should be investigated. The RenalGuard™ System (PLC Medical Systes, 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 theory that creating and maintaining a high urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. This should allow the body to rapidly eliminate contrast, reducing its toxic effects. The RenalGuard System seems to be ideal for the prevention of CI-AKI, by allowing an optimal urine flow rate \>150 ml/h (ideally \>300 ml/h). Preliminary data suggests that the RenalGuard System, by increasing the urine flow rate ≥ 300 ml/h, allows a quick renal first-pass elimination and therefore reduces the risk for contrast nephropathy. The potential benefits of RenalGuard Therapy are intended to reduce the incidence of CI-AKI via a combination of known physiological effects of high urine output including: a) lower concentration of contrast in the kidneys, b) more rapid transit of contrast through the kidneys, c) less overall exposure to toxic contrast, d) potential reduction of oxygen consumption in the medulla of the kidneys. No randomized study has been performed to assess the role of the RenalGuard System as compared to the optimal strategy (sodium bicarbonate infusion plus NAC) in high and very-high risk patients to prevent CI-AKI.

Eligibility criteria: Inclusion Criteria:

1. Age \>=18 years
2. Chronic kidney disease (estimated glomerular filtration rate \<=30 ml/min/1.72 m2) and/or
3. Risk score for contrast nephropathy ≥11 (according to the Mehran score; J Am Coll Cardiol 2004; 44: 1393-1399)

Exclusion Criteria:

1. Pregnancy
2. Heart failure (NYHA functional class III-IV)
3. Acute pulmonary edema
4. Acute myocardial infarction
5. Recent (\<=2 days) contrast media exposure
6. Patients enrolled in concomitant studies
7. Administration of theophylline, dopamine, mannitol and fenoldopam.
8. End-stage CKD (patients on chronic dialysis)
9. Systemic hypotension (systolic blood pressure \< 100 mg/dl).
10. Multiple myeloma

Primary outcomes:
measure: Number of Participants With Contrast-induced Acute Kidney Injury
timeFrame: at 48 hours following contrast exposure
Secondary outcomes:
measure: Rate of Kidney Injury and Major Adverse Events
timeFrame: 7 days
measure: Changes in the Serum Cystatin C Concentration at 24 and 48 Hours After Contrast Exposure
timeFrame: 7 days
measure: Changes in the Urine and Serum NGAL Concentration After Contrast Exposure
timeFrame: 7 days
measure: the Rate of Acute Renal Failure Requiring Dialysis
timeFrame: 1 month
measure: The Rate of In-hospital Major Adverse Events (i.e. Acute Myocardial Infarction, c) Renal Failure Requiring Dialysis, and d) Acute Pulmonary Edema)
timeFrame: 1 month
measure: The Cost-effectiveness Ratio.
timeFrame: 1 month
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Unversity of Ferrara, Department of Cardiology
city: Milan
country: Italy
facility: IRCCS Multimedica
city: Modena
country: Italy
facility: Unversity School of Medicine of Modena, Deparment of Cardiology
city: Naples
country: Italy
facility: Clinica Mediterranea
Study officials:
affiliation: Clinica Mediterranea, Naples,. ITALY
name: Carlo Briguori, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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