The new meta-analysis, presented as a poster by researchers from the University of Texas Health Sciences Center, San Antonio, USA, during the 2017 American College of Cardiology meeting on 19 March, included data from nine studies comparing the use of RenalGuard to conventional volume expansion. Six were randomised controlled trials using RenalGuard in the treatment of patients undergoing various cardiovascular diagnostic and therapeutic interventions. Primary outcomes in the analysis included the incidence of contrast-induced acute kidney injury and relative risk. Secondary outcomes included the incidence of mortality, major adverse cardiovascular events, and the need for post-procedure dialysis.
The investigators found RenalGuard therapy to be associated with a significant risk reduction in contrast-induced acute kidney injury compared to the control therapy (Relative risk: 0.409; 95% CI: 0.282-0.591; p<0.001).
RenalGuard measures a patient’s urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults. A number of studies have demonstrated RenalGuard’s ability to protect patients from AKI following catheterisation procedures when compared to the standard of care.
“We are very pleased that independent analysis of the growing clinical data continues to support the potential of RenalGuard to significantly reduce the serious health risks associated with acute kidney injury related to cardiac interventional procedures,” said Andrew Halpert, president of RenalGuard Solutions. “In doing so, we believe RenalGuard offers the potential to safely bring the important benefits of such medical interventions to more patients, especially those who have been considered at too high risk due to their reduced kidney function.”
Halpert further noted that a US pivotal clinical trial of RenalGuard was currently on track to complete at the end of 2017, and if positive, the company planned to seek US marketing approval from the FDA in 2018.