Current military conflicts have exposed service members to complex injuries and combat polytrauma. The signature injuries currently seen are combinations of blast injuries (improvised explosive devices), penetrating wounds (projectiles and gunfire) and blunt force trauma, often accompanied by hemorrhagic shock and infection. Each of these injuries put casualties at risk of multisystem organ failure, but in combination have led to alarming rates of respiratory and renal failure. The use of conventional lung rescue strategies on standard ventilators, including lung protective ventilation, airway pressure release ventilation (APRV- a ‘rescue’ ventilator mode) and proning, can prove challenging to rescue severe cases. Additionally, the lack of expertise, equipment, and resources limit therapeutic capability.
The physiologic burden of injury-related sequela is not limited to the lungs, as renal failure occurs in up to 12.5% of patients and contributes to mortality in nearly 30% of combat casualties. A combination of shock, prolonged hypotensive resuscitation, and tissue damage from a blast lead to rhabdomyolsis, acute kidney injury (AKI), and renal failure. Temporary renal replacement therapy can be lifesaving in these cases, as untreated traumatic renal failure has an unacceptably high mortality.
With the changing landscape of combat operations, and the mandate to provide up to 72 hours of prolonged care in the field, sicker patients will present to forward deployed MTFs. These patients have potential for significant ischemia-reperfusion injury with resultant AKI and acute respiratory distress syndrome (ARDS). Therefore, there is a critical need to develop a single ‘bridge’ extracorporeal life support (ECLS) device that can be used in patients with both AKI and ARDS. The goal of this bridge therapy is to keep patients alive until more definitive support and transport can be achieved. This device must be able to fully support CO2 removal while replacing the function of the kidneys through a standard dialysis catheter, and include the ability to use each mode separately. The research project award recipient was selected from the Offerors who responded to MTEC’s 17-09-Prototype Development for Extracorporeal Life Support (ECLS) Request for Project Proposals (17-09-ECLS).
Development of Multi-Functional Extracorporeal Life Support (ECLS) System for Lung and Kidney Support: Pneuma-K ECLS System (Project Completed)
Project Team: Human Biomed, Inc., University of Vermont, Burlington
Award Amount: $1,000,000
Project Duration: 12 Months
Project Objective: Soldiers in battlefield situations are often subject to severe injury. The use of conventional lung rescue strategies on standard ventilators delivers limited treatment capacity, especially in severe cases. Further, traumatic acute kidney injury (AKI) has an extremely high mortality rate and temporary renal replacement therapy can be lifesaving in these cases. An easily implemented and effective device to replace impaired lung and kidney functions would provide a significant novel therapy.
Thus, a novel extracorporeal life support (ECLS) system which simultaneously supports impaired lung and kidney functions is proposed. The principal feature of the ECLS system is the use of a multi-functional detoxifying filter (MDF). The MDF is a patented filter apparatus which performs multiple blood purification functions including high volume hemofiltration, blood oxygenation, and carbon dioxide removal. Thus, it supports impaired lung and kidney functions. The MDF also conducts the adsorption of hemofiltrate such that various uremic toxins and inflammatory cytokines are removed from the patient. These purification methods are all integrated into a single filter unit in the MDF.
Human Biomed, Inc. has made great progress toward the advancement of prototype development. The team has recently demonstrated in vivo proof of concept of an extracorporeal life support (ECLS) device to simultaneously replace impaired lung and kidney functions. The principal feature of their system is the use of a multi-functional detoxifying filter (MDF). The MDF is a patented filter apparatus which performs multiple blood purification functions including high volume hemofiltration, blood oxygenation, and carbon dioxide removal. Thus, it effectively supports lung and kidney functions These purification methods are all integrated into a single filter unit in the MDF. Their animal work in a porcine model showed that their device was able to consistently oxygenate incoming blood and remove carbon dioxide from incoming blood, and prohibit the advancement of renal dysfunction, inhibiting the increase in uremic toxin concentrations, while providing continuous renal replacement therapy (CRRT). We look forward to hearing about their continued progress.