Clinical trial NCT01456013: Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contrast Induced Nephropathy
Lead sponsor: CardioRenal Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 326
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Contrast Induced Nephropathy
timeFrame: 72 hours
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 90 days
measure: Mean peak increase in serum creatinine post contrast administration
timeFrame: 72 hours
measure: Proportion of patients who develop CIN at 7 days post contrast administration
timeFrame: 7 days
measure: Proportion of patients who maintain a rise in serum creatinine at 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Torrance
country: United States
facility: Torrance Medical Center
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan
state: Illinois
city: Naperville
country: United States
facility: Advocate Health
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Brighton
country: United States
facility: St. Elizabeth's Hospital
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Healthcare
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Saint Charles
country: United States
facility: St. Joseph Medical Center
state: Missouri
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Raleigh
country: United States
facility: Rex Hospital
state: North Carolina
city: Bartlesville
country: United States
facility: St. John Research Institute
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Austin
country: United States
facility: Austin Heart Central
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White
state: Texas
city: Round Rock
country: United States
facility: Austin Heart Round Rock
state: Texas
Study officials:
affiliation: Northwestern University
name: Charles Davidson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Richard Solomon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Roxana Mehran, MD
role: PRINCIPAL_INVESTIGATOR
References: