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Lookup NU author(s): Dr Heather Lambert, Shaun HiuORCiD, Dr Malcolm Coulthard, Professor John MatthewsORCiD, Dr Eva-Maria Holstein, Dr Rachel Agbeko, Joe Bulmer, Richard Feltbower, Dr Michael Grayling, Rebecca Harrison, Emerita Professor Elaine McCollORCiD, Shriya Sharma, Dr Alison SteelORCiD, Jenn Walker, Emeritus Professor Michael Whitaker, Dr Jim Wightman, Dr Nina WilsonORCiD, Ruth Wood
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
Copyright © 2023 The Author(s).Objectives: Renal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformité Européenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH). Design: Nonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence. Setting: Clusters were six U.K. PICUs. Patients: Babies less than 8 kg requiring RRT for fluid overload or biochemical disturbance. Interventions: In controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances. Measurements and Main Results: At closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between. Conclusions: NIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.
Author(s): Lambert H, Hiu S, Coulthard MG, Matthews JNS, Holstein E-M, Crosier J, Agbeko R, Brick T, Duncan H, Grant D, Mok Q, Nyman AG, Pappachan J, Boucher C, Bulmer J, Chisholm D, Cromie K, Emmet V, Feltbower RG, Ghose A, Grayling M, Harrison R, Kennedy CA, Mccoll E, Morris K, Norman L, Office J, Parslow R, Pattinson C, Sharma S, Smith J, Steel A, Steel R, Straker J, Vrana L, Walker J, Wellman P, Whitaker M, Wightman J, Wilson N, Wirz L, Wood R
Publication type: Article
Publication status: Published
Journal: Pediatric Critical Care Medicine
Year: 2023
Volume: 24
Issue: 7
Pages: 604-613
Print publication date: 01/07/2023
Acceptance date: 02/04/2023
Date deposited: 01/08/2023
ISSN (print): 1529-7535
ISSN (electronic): 1947-3893
Publisher: Lippincott Williams and Wilkins
URL: https://doi.org/10.1097/PCC.0000000000003220
DOI: 10.1097/PCC.0000000000003220
PubMed id: 36892305
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