Purity and Stability of Online-Prepared Hemodiafiltration Fluid after Storage

Corradi, Valentina; Cruz, Dinna N.; Vázquez-Rangel, Armando; Furlan, Felipe F.; Grillone, R.; Bonaccorsi, A.; Cazzavillan, S.; Cal, Massimo de; Frisone, P.; Morea, A.; Brendolan, Alessandra; Rassu, Mario; Ronco, Claudio

doi:10.1159/000346095

Cited by 4 publications

(4 citation statements)

References 28 publications

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“…Using IHD machines to locally produce CKRT fluid is uncommon but not entirely novel [ 25 – 28 ]. The Cleveland Clinic, for example, has produced their own CKRT solutions using IHD machines for decades [ 26 – 28 ].…”

Section: Discussionmentioning

confidence: 99%

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

Teixeira,

Saa,

Kaucher

et al. 2023

BMC Nephrol

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Background On December 29, 2021, during the delta wave of the Coronavirus Disease 2019 (COVID-19) pandemic, the stock of premanufactured solutions used for continuous kidney replacement therapy (CKRT) at the University of New Mexico Hospital (UNMH) was nearly exhausted with no resupply anticipated due to supply chain disruptions. Within hours, a backup plan, devised and tested 18 months prior, to locally produce CKRT dialysate was implemented. This report describes the emergency implementation and outcomes of this on-site CKRT dialysate production system. Methods This is a single-center retrospective case series and narrative report describing and reporting the outcomes of the implementation of an on-site CKRT dialysate production system. All adults treated with locally produced CKRT dialysate in December 2021 and January 2022 at UNMH were included. CKRT dialysate was produced locally using intermittent hemodialysis machines, hemodialysis concentrate, sterile parenteral nutrition bags, and connectors made of 3-D printed biocompatible rigid material. Outcomes analyzed included dialysate testing for composition and microbiologic contamination, CKRT prescription components, patient mortality, sequential organ failure assessment (SOFA) scores, and catheter-associated bloodstream infections (CLABSIs). Results Over 13 days, 22 patients were treated with 3,645 L of locally produced dialysate with a mean dose of 20.0 mL/kg/h. Fluid sample testing at 48 h revealed appropriate electrolyte composition and endotoxin levels and bacterial colony counts at or below the lower limit of detection. No CLABSIs occurred within 7 days of exposure to locally produced dialysate. In-hospital mortality was 81.8% and 28-day mortality was 68.2%, though illness severity was high, with a mean SOFA score of 14.5. Conclusions Though producing CKRT fluid with IHD machines is not novel, this report represents the first description of the rapid and successful implementation of a backup plan for local CKRT dialysate production at a large academic medical center in the U.S. during the COVID-19 pandemic. Though conclusions are limited by the retrospective design and limited sample size of our analysis, our experience could serve as a guide for other centers navigating similar severe supply constraints in the future.

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Section: Discussionmentioning

confidence: 99%

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

Teixeira,

Saa,

Kaucher

et al. 2023

BMC Nephrol

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“…Corradi et al similarly produced online-prepared hemodiafiltration fluid and demonstrated stable clinical electrolyte composition (sodium, potassium, chloride, and calcium), did not identify macrocrystalization (despite changes in pH and P co 2 ), and had negative fluid cultures, endotoxin, and molecular testing after 7 days of storage. 20 …”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

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Rationale & Objective Since 1994, the Nephrology and Hypertension Department at the Cleveland Clinic has prepared and used bicarbonate-based solution for continuous venovenous 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 & 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 between 2011 and 2019 with continuous kidney replacement therapy, 59% were men, 71% were White, 40% had diabetes mellitus, and 74% presented with acute kidney injury. 98% of patients were treated with CVVHD using CCUPS, while the remaining 2% were treated with either continuous venovenous hemofiltration or continuous venovenous hemodiafiltration using commercial solution. The prescribed and delivered effluent doses were 24.8 (IQR) versus 20.7 mL/kg/h (IQR), respectively. CCUPS was as effective in restoring electrolyte and serum bicarbonate levels and reducing phosphate, creatinine, and serum urea nitrogen levels as compared with packaged commercial solution over a 3-day period following initiation of dialysis, with a comparable effluent dose. Among those with acute kidney injury, mortality was similar to that predicted with the 60-day acute kidney injury predicted mortality score (r = 0.997; CI: 0.989-0.999). At our institution, the cost of production for 1 L 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.

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“…Corradi et al, 5 evaluating a similar method, also showed no clinically relevant change in electrolytes over a much longer storage period, 96 hours, and assert lack of clinically relevant change to 168 hours. In any case, most CVVHD treatments involve frequent blood chemistry monitoring, and the effect of even major electrolyte deficits in the fluid would probably be detected long before adverse clinical impact.…”

mentioning

confidence: 99%

DIY: Ultrapure Home Brew Dialysate for the ICU?

Wright

Meyer

2021

Kidney Medicine

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Purity and Stability of Online-Prepared Hemodiafiltration Fluid after Storage

Cited by 4 publications

References 28 publications

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

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

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

DIY: Ultrapure Home Brew Dialysate for the ICU?

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