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

Chronic Kidney Diseases Clinical Trial

Official title:
Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04877847
Study type Interventional
Source Sonogenix
Contact
Status Terminated
Phase N/A
Start date September 24, 2021
Completion date January 23, 2023
View Details
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