# Kidney Support in Pediatric Patients Using an Ultrafiltration Device

> **NIH NIH R44** · KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT · 2022 · $763,118

## Abstract

Abstract
Koronis Biomedical Technologies (KBT) proposes to develop and fully evaluate a renal replacement therapy
(RRT) machine specifically targeted for critically-ill small children and neonates with acute kidney injury (AKI),
fluid overload, and kidney failure. In recent years, continuous renal replacement therapy (CRRT) has emerged
as the preferred method for providing kidney support to these patients, especially those who are
hemodynamically unstable. Continuous veno-venous hemofiltration (CVVH) is a form of CRRT built on
hemofiltration: waste products and fluid in plasma are removed from the blood by a pressure gradient over a
filter, while a replacement fluid is infused to maintain fluid balance. Unfortunately, neonates infrequently
receive renal replacement therapy due to the technical challenges of traditional CRRT machines that make
therapy initiation very difficult, even at experienced tertiary children’s hospitals. Machines designed for adult-
sized patients, but commonly used in pediatric care, require large catheters, tubing, and filters. This results in a
high extracorporeal volume (ECV, the total volume of blood in the external circuit—the tubing and hemofilter)
relative to a small patient’s size, as well as higher blood flows, higher clearance rates, and higher risks.
Numerous medical centers do not even offer CRRT to infants, let alone for critically-ill neonates or premature
infants, due to the inherent risks. At therapy initiation, a volume of fluid roughly equivalent to the ECV must be
injected into the blood circuit to “prime” the pump. For CRRT in larger children and adults, the priming fluid is
simply saline. If, however, the amount of fluid required to prime the circuit is greater than 10% of the patient’s
total blood volume, the saline fluid could significantly dilute the patient’s blood, leading to hemodynamic
instability. To avoid this outcome, a donor “blood prime” is used, though it is not without risks, such as
hypocalcemia, acidosis, hyperkalemia, and a loss of platelets and coagulation functions. KBT’s Phase II SBIR
project proposes to bring a new CRRT device with a lower ECV to market that is specifically targeted for small
children and neonates, eliminating the need for blood primes. The performance and safety of the proposed
highly integrated CRRT system will be evaluated in a clinical trial.

## Key facts

- **NIH application ID:** 10407077
- **Project number:** 5R44DK127631-02
- **Recipient organization:** KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT
- **Principal Investigator:** Robert J Knuesel
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $763,118
- **Award type:** 5
- **Project period:** 2021-05-18 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10407077

## Citation

> US National Institutes of Health, RePORTER application 10407077, Kidney Support in Pediatric Patients Using an Ultrafiltration Device (5R44DK127631-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10407077. Licensed CC0.

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