Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
This is a multi-center, randomized, controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure. The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US. All subjects will be pre- treated with 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control. Subjects will have clinical follow-up examination 30 days post index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions.
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting.
Henry Ford Hopsital
Detroit, Michigan, United States
McLaren Northern Michigan
Petoskey, Michigan, United States
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States
UT Health San Antonio
San Antonio, Texas, United States
Primary Efficacy Endpoint
Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)
Time frame: 48 hours
Primary Safety Endpoint
Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)
Time frame: 30 days
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
Time frame: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.5 mg/dl or greater than or equal to 25 percent rise in SCr
Time frame: at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Incidence of contrast-induced nephropathy
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
Time frame: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
defined as greater than or equal to 2-fold rise in SCr, increase in SCr to greater than or equal to 4.0 mg/dl, or initiation of RRT
Time frame: within 30 days after index procedure
Incidence of Post Contrast Acute Kidney Injury
defined as greater than or equal to 0.3 mg/dl or greater than or equal to 25 percent rise in SCr
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Time frame: within 96 hours post-contrast exposure or need for RRT
Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)
defined as Stage 1 - Serum Creatinine 1.5-1.9 times baseline or greater than or equal to 0.3 mg/dL increase, Stage 2 - Serum Creatinine 2-2.9 times baseline, Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to greater than or equal to 4 mg/dL or Initiation of renal replacement therapy
Time frame: within 96 hours of index procedure
Maximum percent-change
Maximum percent-change in SCr
Time frame: within 96 hours after contrast exposure
Absolute and percent-change in estimated glomerular filtration rate (eGFR)
as calculated using the Modification of Diet in Renal Disease Study Group (MDRD)
Time frame: from baseline within 96 hours after contrast exposure.
Total urine output
defined as the amount of urine collected in cc/hour.
Time frame: through baseline procedure
Hospitalization
Hospital length of stay
Time frame: following the baseline procedure through discharge from the hospital up to 30 days
Intensive Care
Intensive care unit length of stay
Time frame: following the baseline procedure through discharge from the Intensive Care Unit up to 30 days