The Production, Efficacy, and Safety of Machine-Generated Bicarbonate Solution for Continuous Veno-venous Hemodialysis (CVVHD): The Cleveland Clinic Method

Abstract Rationale and Objective Since 1994, the Nephrology and Hypertension Department at the Cleveland Clinic has prepared and used bicarbonate based solution for continuous veno-venous hemodialysis (CVVHD) using a standard volumetric hemodialysis machine rather than purchasing from a commercial vendor. This report describes the process of producing Cleveland Clinic UltraPure Solution (CCUPS), quality and safety monitoring, economic costs, and clinical outcomes. Study Design Retrospective study Setting and Participants CVVHD experience at Cleveland Clinic, focusing on dialysate production, institutional factors and patients requiring continuous kidney replacement therapy. Production is shown at www.youtube.com/watch?v=WGQgephMEwA. Outcomes Feasibility, safety and cost Results Of 6,426 patients treated with continuous kidney replacement therapy between 2011 and 2019, 59% were male and 71% White; 40% had diabetes mellitus and 74% presented with acute kidney injury. Ninety-eight percent of patients were treated with CVVHD using CCUPS, while the remaining 2% were treated with either continuous veno-venous hemofiltration (CVVHF) or continuous veno-venous hemodiafiltration (CVVHDF) using commercial solution. The prescribed and delivered effluent dose were 24.8 ml/kg/hour (IQR) versus 20.7 ml/kg/hour (IQR), respectively. CCUPS was as effective in restoring electrolyte, serum bicarbonate, and reducing phosphate, creatinine, and blood urea nitrogen levels as compared to packaged commercial solution over three-day period following initiation of dialysis, with comparable effluent dose. Among those with AKI, mortality was similar to that predicted with the 60-day AKI predicted mortality score [r = 0.997 (0.989-0.999)]. At our institution, the cost of production for one liter of CCUPS is $0.67 which is considerably less than the cost of commercially purchased fluid. Limitations Observational design without a rigorous control group Conclusions CVVHD using locally generated dialysate is safe and cost-effective.