Protocol for Local On-Site Dialysate Production for Continuous Renal Replacement Therapy during the COVID-19 Pandemic

Abstract

Acute kidney injury frequently occurs in patients with COVID-19 and injury severe enough to require renal replacement therapy (RRT) is a common complication among critically-ill patients.[1-3] During the surge, there was a high demand for dialysate for continuous RRT, and this increase in demand coupled with vulnerabilities in the supply chain necessitated alternative approaches, including internal production of dialysate. Using a standard hemodialysis machine and off the shelf supplies as per Federal Drug Administration (FDA) guidelines, we developed a method for on-site dialysate production that is adaptable and can be used to fill multiple bags at once. The use of a central reverse osmosis unit, dedicated hemodialysis machine, sterile bags with separate ports for fill and use, and frequent testing will ensure stability, sterility and therefore safety of produced dialysate. Dialysate made in house was tested and showed both stability and sterility for at least 30 hours. This detailed description of our process for generating dialysate can serve as a guide for other programs experiencing similar vulnerabilities in the demand vs. supply of dialysate.

Rapid implementation of an emergency on-site CKRT dialysate production system during the COVID-19 pandemic

“…In July 2020, the nephrology division at UNM developed a backup plan for CKRT provision using locally generated fluid based largely on protocols previously published in the medical literature [ 17 , 18 ] and online [ 19 ] early in the pandemic. The equipment and supplies used included traditional intermittent hemodialysis (IHD) machines (Gambro Phoenix, Baxter), Revaclear dialyzers (Baxter), Naturalyte hemodialysis acid concentrate (Fresenius Medical Care, Waltham, MA), BiCart powdered sodium bicarbonate concentrate (Baxter), and sterile 3-L and 4-L bags (Exactamix Empty EVA Bag, Baxter) normally used for total parenteral nutrition (TPN) (Figs.…”

“…However, we rapidly encountered a relative shortage of TPN bags, which we were suddenly using at a much higher rate than normal as an institution, ultimately requiring us to procure additional bags from other hospitals in the area. To reduce bag wastage, we ultimately extended the shelf life of our CKRT solutions up to 48 h after confirming reassuring endotoxin and bacterial culture results at 48 h. In addition, we did not have access to Y-connectors utilized by others [ 17 , 28 ]. but rather connected one bag to each IHD machine at a time.…”

Effect of continuous renal replacement therapy on the clinical efficacy and pharmacokinetics of polymyxin B in the treatment of severe pulmonary infection

“…With the abuse of antibiotics in recent years, the incidence of multi-drug resistant gram-negative bacterial infections has been increasing year by year, and polymyxin B has become a common drug for the clinical treatment of severe pulmonary infections caused by Gram-negative bacteria. At the same time, the study believes that regular monitoring of polymyxin B plasma concentrations and timely adjustment can contribute to improve efficacy and reduce toxicity and side effects [ 11 ].…”

Care of the Hospitalized Patients with Kidney Failure during COVID-19 Pandemic: Lessons Learned

“…8 Local manufacturing of bicarbonate dialysate required US Food and Drug Administration collaboration and approval. 8 As with other medical specialties during this period, nephrologists also needed to weigh the possibility of rationing dialysis to those who could most benefit—and thus withholding from others—if conservative measures could not stave off dialysis. Unlike with ventilators, the United States did not have a national stockpile of KRT machines and disposables, and it is possible that patients died because of lack of timely dialysis.…”

“…7 Because of high demand, bicarbonate-based solutions for CKRT became in short supply, and alternate solutions, including lactate-based solutions and homemade CKRT solutions made from HD machines, had to be used in certain institutions. 8 Local manufacturing of bicarbonate dialysate required US Food and Drug Administration collaboration and approval. 8 As with other medical specialties during this period, nephrologists also needed to weigh the possibility of rationing dialysis to those who could most benefit-and thus withholding from others-if conservative measures could not stave off dialysis.…”