Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury

Chronic Kidney Diseases Clinical Trial

— LOTUS  

Official title:

Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04877847
• Other study ID #: CP-001
• Status: Terminated
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: April 2023
• Source: Sonogenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant is greater than or equal to 18 years
• Baseline renal dysfunction defined as one of the following:

1. eGFR greater than 30

2. 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).

3. 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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Contrast-induced Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Low-frequency therapeutic ultrasound (LOTUS)
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions.
• LOTUS System with Ultrasound Disabled
Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Sonogenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)	48 hours
Primary	Primary Safety Endpoint	Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)	30 days
Secondary	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	at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Secondary	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	at 72 hours post-contrast exposure or need for renal replacement therapy (RRT)
Secondary	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	within 96 hours post-contrast exposure or need for RRT
Secondary	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	within 30 days after index procedure
Secondary	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	within 96 hours post-contrast exposure or need for RRT
Secondary	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	within 96 hours of index procedure
Secondary	Maximum percent-change	Maximum percent-change in SCr	within 96 hours after contrast exposure
Secondary	Absolute and percent-change in estimated glomerular filtration rate (eGFR)	as calculated using the Modification of Diet in Renal Disease Study Group (MDRD)	from baseline within 96 hours after contrast exposure.
Secondary	Total urine output	defined as the amount of urine collected in cc/hour.	through baseline procedure
Secondary	Hospitalization	Hospital length of stay	following the baseline procedure through discharge from the hospital up to 30 days
Secondary	Intensive Care	Intensive care unit length of stay	following the baseline procedure through discharge from the Intensive Care Unit up to 30 days