US-based medical device company RenalGuard Solutions reported that its RenalGuard Therapy has demonstrated better results in KIDNEY clinical trial, compared to standard-of-care hydration.

The company said that its RenalGuard system would protect cardiopulmonary bypass (CPB) patients, undergoing cardiac surgery, from Acute Kidney Injury (AKI).

RenalGuard Solutions chief medical officer Howard Levin said: “The KIDNEY trial adds to a growing body of clinical evidence showing that RenalGuard Therapy is a very effective means of preventing acute kidney injury in at-risk patients.

“Last month, a 700+-patient, multi-centre, randomized clinical trial found RenalGuard to be superior to the POSEIDON protocol in preventing contrast-induced AKI.”

Automated fluid management system RenalGuard Therapy protects patients from AKI

According to the company, AKI is one of the most common major surgical complications, with elective cardiac surgeries performed across the world.

AKI is characterised by an increase in serum creatinine greater than 50% in the days post-procedure and is said to complicate patient recovery, extend recovery time and promote in-hospital and long-term mortality after surgery.

The company said that it has designed the RenalGuard Therapy to deploy the automated fluid management system with a physician-prescribed loop diuretic.

The automated fluid management system is set to measure urine output and replace it in real-time with an equal volume of sterile saline and induce high urine output rates to protect against AKI.

In addition, the RenalGuard System also allows the infusion of a bolus of fluid at the user’s request and is capable of adjusting matched hydration considering other fluid sources. The system can be used for a net fluid gain over and above matched hydration or a net fluid loss.

The KIDNEY clinical trial is a 220 patient, randomised study evaluating automated diuresis technology RenalGuard Therapy, compared to standard hydration, in patients at-risk for AKI.

The patients were randomised into a RenalGuard Therapy treatment group and a control group, managed with standard-of-care hydration. The study has met the primary endpoint of reducing onset of AKI within 48 hours of surgery.

History of diabetes, anaemia, estimated Glomerular Filtration Rate (eGFR), anticipated cardiac surgery time of more than 120 minutes and Log EuroScore of greater than 5 include the risk factors for AKI.

The results of the study were presented at the American Society of Nephrology’s Kidney Week meeting at Washington DC, US.