Status:
TERMINATED
Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury
Lead Sponsor:
Sonogenix
Conditions:
Contrast-induced Nephropathy
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Participant is greater than or equal to 18 years
- Baseline renal dysfunction defined as one of the following:
- eGFR greater than 30
- eGFR 30-45, with or without risk factors for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- eGFR 45-60, with at least one risk factor for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- Participant is presenting for a planned percutaneous coronary intervention (PCI)
- Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
- Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
- Participant has provided written informed consent.
- Participant is willing to comply with study follow-up requirements.
- Exclusion Criteria
- Participant is anuric or currently undergoing renal replacement therapy.
- Participant is currently taking oral nitrates.
- Participant is undergoing a procedure requiring selective cannulation and injection of contrast into the renal arteries.
- Participant presented with ST-segment elevation myocardial infarction.
- Participant has a metal implant in the hip or lumbar spine.
- Participant received or is anticipated to receive additional intravenous or intraarterial contrast from 7 days prior to cardiac catheterization to 4 days after cardiac catheterization.
- Addition, discontinuation, or dose change of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, diuretic, trimethoprim, non-steroidal anti-inflammatory drugs, cimetidine, or metoclopramide with 7 days prior to cardiac catheterization.
- Participant has a known allergy to contrast medium that cannot be adequately pre-medicated.
- Participant has new-onset heart failure with New York Heart Association (NYHA) classification of III or IV within 30 days prior to the index procedure.
- Recent stroke within 90 days prior to the index procedure.
- Participant has known or suspected active infection at the time of the index procedure.
- Participant is pregnant and/or breast-feeding or intends to become pregnant during the time of the study.
- Participant is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
- Participant is known to be incarcerated, mentally incompetent, and/or alcohol or drug abuser.
- Participant is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or subject is planning to participate in such studies prior to the completion of this study.
Exclusion
Key Trial Info
Start Date :
September 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04877847
Start Date
September 24 2021
End Date
January 23 2023
Last Update
April 12 2023
Active Locations (4)
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1
Henry Ford Hopsital
Detroit, Michigan, United States, 48202
2
McLaren Northern Michigan
Petoskey, Michigan, United States, 49770
3
University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States, 15213
4
UT Health San Antonio
San Antonio, Texas, United States, 78229