Submission
| Title: | Miniaturized Manual Renal Replacement Therapy: Pre-clinical Model for Neonatal Applications |
| Presenter: | Carl Russell III |
| Institution: | Indiana University School of Medicine Purdue University School of Biomedical Engineering |
| Authors: | a,b Carl Russell III, aAngus Stergar, cGiovanni Ceschia, aRose Odom, a,dMichelle C. Starr, eJolyn Morgan, eAmanda Snyder, fDenise Hasson, gEd Pulte, hApaara K Chawla, c,iStuart Goldstein, a,b,dDanielle E. Soranno, a,dCara L. Slagle aIndiana University School of Medicine, Department of Pediatrics, Indianapolis, IN, USA; bPurdue University Weldon School of Biomedical Engineering, West Lafayette, IN, USA; cCincinnati Children’s Hospital and Indiana University Health, Cincinnati, OH, USA; dRiley Hospital for Children, Indianapolis, IN, USA; eCincinnati Children’s Hospital, Cincinnati, OH, USA; fNew York University Langone Health, New York, NY, USA; gExThera Medical Inc, Martinez, CA ; hGeorge Washington University, Washington, DC, USA; iUniversity of Cincinnati College of Medicine, Department of Pediatrics, Cincinnati, OH, USA |
Abstract
| Background/Significance/Rationale: | Neonates weighing <2.5 kg with fluid overload (FO) and/or acute kidney injury (AKI) have limited treatment options. Peritoneal dialysis is constrained by skin integrity and reliable ultrafiltration (UF) challenges, whereas extracorporeal devices are expensive and hindered by the need for large-bore dual-lumen vascular access. The Brophy KitTM (BK), a manual, single-lumen, low-cost dialysis kit is designed for <2.5 kg patients. |
| Methods: | Healthy male 600–800-gram rats had 3 French central venous catheters placed. The BK was primed with heparinized crystalloid. Blood aspiration and infusion (3mL) marked one cycle. Four cycles were performed before ultrafiltration (UF) to determine prime tolerance. Replacement infusion (PlasmaLyteTM) was initiated at 0.5 mL/min to account for anticipated UF (0.5 mL per cycle/1 min). Goal UF cycles equaled the number of cycles required to UF 10% total blood volume (TBV). Respiratory rate (RR) was recorded at baseline, 5% TBV UF, and 10% TBV UF. Blood was collected during central line placement (baseline), pre-ultrafiltration, and at sacrifice. UF was weighed at experiment completion to compare expected vs. observed. |
| Results/Findings: | Nine rodents underwent the procedure; one was terminated before UF (loss of access). RRs demonstrated no difference at experimental milestones. All eight rodents remained hemodynamically stable. Percent difference between serum electrolytes vs. PlasmaLyteTM was minimal (Na {4.1%}; K {5.15%}, Cl {0.25%}). Prescribed vs actual UF volume differed by 11.4% (day 1) and 12.0% (day 2). |
| Conclusions/Discussion: | Initial rodent experiments using small-caliber vascular access demonstrate feasibility and procedural tolerance, electrolyte stability, and device reliability. A two-person user approach might be preferred to achieve prescribed UF volumes. Passive clearance and normalization to PlasmaLyteTM were observed. |
| Translational/Human Health Impact: | Results are encouraging. The Brophy KitTM could support ultrafiltration in infants weighing less than 2.5 kg. |
