Kidney Dialysis System Augmentation
Overview
According to the CDC one in ten adults has some form of Chronic Kidney Disease, resulting in 660,000 Americans suffering from end stage renal disease (ESRD, a.k.a kidney failure). From a 10-year experience of inpatient and outpatient medical records for 433 patients with ESRD requiring chronic hemodialysis, up to 70% of patients requiring Continuous Renal Replacement Therapy were on antibiotics. Of all ICU admission, up to 65% of patients admitted to an adult ICU need antibiotics to be added to the dialysate to fight infections. This process for administering antibiotics to a patient on dialysis requires a sterile room, and up to 2 hours for the antibiotics to be added to the dialysis bag. Currently there is not a more efficient process for adding antibiotics to dialysis solutions. Researchers at Drexel University and NYU have developed a technology that allows for a more efficient addition of antibiotics to a Continuous Renal Replacement Therapy (CRRT) solution and other types of dialysis solutions (e.g. peritoneal dialysis) without the requirement for a sterile environment. This device could save hospitals and patients both time and money while also speeding the access of dialysis patients to much needed therapeutic regimens. To assure adequate level of antibiotic is maintained in the body a special dosing algorithm has been developed as well.
The management of infection in the intensive care unit (ICU) represents an ongoing challenge for critical care clinicians. The critically ill represent a unique population, either presenting with infection complicated by systemic inflammation (sepsis) or being predisposed to such complications by virtue of the underlying disease process. Multi-trauma, hematological malignancy, and acute kidney injury (AKI) are relevant examples in which organ function is already significantly disturbed and subsequent infection is common.
Successful therapy for infection encountered in the ICU setting relies on early recognition of infection and the timely application of antibiotics against the contributing pathogen. Mortality rates in the ICU setting remain high, while antibiotic resistance is becoming more prevalent, suggesting further improvements are urgently needed. Optimization of antibiotic dosing, such that predefined pharmacokinetic/pharmacodynamic (PK/PD) targets for maximal bacterial killing are achieved is paramount.
In ICU, continuous renal replacement therapy is often employed as a treatment modality for AKI, fluid overload, and sepsis. In those needing CRRT, mortality increases to 60%. Further complicating ICU management is the high prevalence of Gram-negative and Gram-positive infections (62% and 47%, respectively). Up to 40% of current dosing regimens for the antimicrobials piperacillin, meropenem, and vancomycin in the adult population have been shown to be inadequate in the setting of CRRT and up to 100% in certain pediatric populations. Utilizing the new dosing strategy developed at Drexel and NYU in the setting of pediatric CRRT, addition of antibiotics to the dialysis solution was completed in minutes in a non-sterile environment, and 100% of patients receiving vancomycin achieved therapeutic serum concentrations.
Applications
- Use in hospitals or any other location where patients need CRRT and other forms of dialysis.
Advantages
- Currently, no CRRT or peritoneal dialysis bags have a vial adaptor port
- Port allows for easier addition of drugs into the CRRT and dialysate solutions, specifically antibiotics
- Port can be used in a non-sterile environment
- Device is recyclable.
Intellectual Property and Development Status
PCT Patent Pending- PCT/US2016/064734
References
Cies JJ, Chopra A. Continuous Infusion Vancomycin Through the Addition of Vancomycin to the Continuous Renal Replacement Therapy Solution in the PICU: A Case Series.
Cies JJ, Chopra A. Therapeutic drug monitoring of continuous-infusion acylovir for disseminated herpes simplex virus infection in a neonate receiving concurrent extracorporeal life support and continuous renal replacement therapy.
FDA IND 129138
ClinicalTrials.gov registration NCT02663596