Kidney support in pediatric patients using an ultrafiltration device

Active Project Grant Awarded Last action

Award ID
R44DK127631
Recipient
Awarding agency
Obligated
$6,184,215

Award facts

Completion date 76% complete
Originally
Funding
  • $5,617,003.09 Federal
  • $567,212.00 Non-federal
Place of performance
Minneapolis, MN 55414, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

Transactions

Action Federal Non-federal Date
Amendment $1,099,700 $0
Amendment $1,100,003 $0
Amendment -$22 $0
Amendment $0 $0
Amendment $378,331 $0
Amendment $378,331 $0
Amendment $763,118 $0
Amendment $763,118 $0
Amendment $0 $0
Amendment $0 $0
Amendment $59,108 $0
Amendment $59,108 $59,108
Amendment $508,104 $0
Original award $508,104 $508,104
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Quick answers

Who received award R44DK127631?

R44DK127631 was awarded to Koronis Biomedical Technologies Corp. by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on May 18, 2021.

How much is award R44DK127631 worth?

$6,184,215 has been obligated on R44DK127631: $5,617,003 in federal funding and $567,212 in non-federal funding.

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