Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients

Study Overview
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Brief Summary
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Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.

Official Title
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A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory

Conditions
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Contrast Induced Nephropathy

Intervention / Treatment
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* Device: RenalGuard Therapy
* Drug: Standard Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent. Subject is scheduled to undergo an elective catheterization procedure Hemodynamically stable At increased risk of developing CIN Subject has agreed to all follow-up testing. Exclusion Criteria: Class 4 Congestive Heart Failure (CHF)or a documented left ventricular ejection fraction < 30% Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed. Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening. Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.) Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state. Patient has severe anemia (hemoglobin < 8.0 g/dL) at screening Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the 7 day follow-up period. Has ruled in for a Serious Heart Attack within 48 hours of the planned procedure Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure. Planned addition, discontinuation or dose adjustment of nephrotoxic drugs Subject has a known hypersensitivity to furosemide and/or the contrast agent being used. 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. Subject is pregnant or breastfeeding. Subject is unable to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Therapy<br>Standard of care for patients at risk of CIN | Drug: Standard Therapy<br>* Standard of care for patients at risk of CIN<br>|
| Experimental: RenalGuard Therapy<br>Induced Diuresis with Matched Replacement | Device: RenalGuard Therapy<br>* Induced Diuresis with matched replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Contrast Induced Nephropathy |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events |  | 90 days | 
| Mean peak increase in serum creatinine post contrast administration |  | 72 hours | 
| Proportion of patients who develop CIN at 7 days post contrast administration |  | 7 days | 
| Proportion of patients who maintain a rise in serum creatinine at 7 days |  | 7 days |