Clinical trial NCT01064895: Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
Official title: Post-Market Observation Study of Intra-renal Drug Delivery (PROVIDE)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Acute Renal Failure
Renal Failure Chronic Contrast Induced
Chronic Kidney Disease
Keywords: Benephit
Acute Kidney Injury
Acute Renal Failure
Contrast Induced Nephropathy
Chronic Kidney Disease
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic acute kidney injury for the patient. Also indicated in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization with the Benephit infusion systems is feasible.

Brief summary: This is a prospective, observational, multi-center study with consecutive enrollment. Up to 500 patients will be enrolled. All (consecutive) adult patients in whom one or more components of the Benephit Infusion System are planned to be used at participating sites are eligible for enrollment. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, AngioDynamics will be able to (1) Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents, (2) Collect user-interface information and overall customer satisfaction, and (3) Monitor post-marketing device performance and safety for ISO quality adherence.

Detailed description: Acute kidney injury, or AKI, is a rapid decline in renal function characterized by a decrease in urine output and/or an increase in serum creatinine (Cr), and is associated with worsened clinical outcomes and increased healthcare costs. AKI may be caused by numerous factors including interruptions or perturbations of renal blood flow or toxins, and often these factors are extra-renal in origin. AKI diagnoses in hospitalized patients are over one million per year and are projected to continue to grow, due largely to the aging population and increasing numbers of medical and invasive procedures performed on the elderly and the ever-increasing prevalence of diabetes mellitus and its medical complications, as well as increasing awareness within the medical community.

Treatment options for established acute kidney injury are limited and consist mainly of fluid and electrolyte balance (diuretics and/or IV fluids) supportive care up until the point that dialysis or other renal replacement therapy (RRT) is required. Despite the advent of newer drugs, more sophisticated RRT equipment, and increased awareness of the problem, little has changed relative to patient outcomes, which remain poor. Similarly, limited options exist in patients with known risk factors for AKI to prevent its development due to iatrogenic causes (e.g., major surgery, exposure to contrast media).

Targeted Renal Therapy allows for direct delivery of therapeutically relevant doses of various pharmacological agents directly to the renal bed, potentially reducing dose limiting side effects of traditional IV therapy. With Targeted Renal Therapy, or TRT, the kidney can metabolize, conjugate, and/or clear a substantial portion of many agents immediately (known as the "renal first-pass" effect), reducing the amount that is returned to the systemic circulation via the renal veins, thus potentially reducing untoward side effects. While the existence of a renal first-pass effect has been hypothesized in the medical literature for some time, it has not been possible to take clinical advantage of this important physiological function prior to the advent of AngioDynamics' TRT. Thus, TRT has the potential to offer an additional preventative or treatment opportunity in those patients at risk for AKI, or with established AKI, respectively.

Eligibility criteria: Inclusion Criteria:

* Physician-determined need for Benephit device/Targeted Renal Therapy
* Age \>=18 years
* Ability to provide written informed consent

Exclusion Criteria:

* Patients who are participating in another IRB approved research study that precludes simultaneous enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Miramar
country: United States
facility: HealthwoRx South Florida Research Solutions
state: Florida
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Munster
country: United States
facility: Cardiology Associates of NW Indiana
state: Indiana
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Bowling Green
country: United States
facility: Sahetya Medical Institute
state: Kentucky
city: Bowling Green
country: United States
facility: Western Kentucky Heart and Lung
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: St. Charles
country: United States
facility: St. Joseph Health Center
state: Missouri
city: Chambersburg
country: United States
facility: Chambersburg Hospital
state: Pennsylvania
city: Layton
country: United States
facility: Utah Cardiology PC
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
References: