REMEDIAL III is a 700 patient, randomized, investigator-driven clinical trial designed to evaluate the ability of the two most successful patient “tailored hydration regimens” to protect at-risk patients from CI-AKI. It compared RenalGuard Therapy with left ventricular end-diastolic pressure (LVEDP)-guided hydration (the “POSEIDON” method).
The data showed RenalGuard Therapy to be superior to LVEDP-guided hydration for the prevention of CI-AKI, as demonstrated by a significantly lower incidence of CI-AKI and/or pulmonary edema, and a lower incidence of major adverse events one month post-treatment. Overall 10.3% of patients (36/351) treated with LVEDP-guided hydration developed CI-AKI and/or pulmonary edema, compared with 5.7% (20/351) of patients treated with RenalGuard Therapy. One month post-treatment, 12% of patients (44/351) treated with LVEDP suffered major adverse events including dialysis, sustained kidney damage, acute pulmonary edema, and death vs. 7.1% (21/351) treated with RenalGuard Therapy.
The investigators concluded that RenalGuard Therapy is superior to the LVEDP-guided hydration regimen to prevent the composite of CI-AKI and/or acute pulmonary edema in high-risk patients.