The Infant KIdney Dialysis and Utrafiltration (I-KID) Study: A Stepped-Wedge Cluster-Randomized Study in Infants, Comparing Peritoneal Dialysis, Continuous Venovenous Hemofiltration, and Newcastle Infant Dialysis Ultrafiltration System, a Novel Infant Hemodialysis Device.

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.
Competing Interests: Drs. Lambert’s, Matthews’s, Holstein’s, Agbeko’s, Duncan’s, Mok’s, Ghose’s, Kennedy’s, McColl’s, Whitaker’s, Wightman’s, and Wilson’s institutions received funding from the U.K. National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation Program (EME). NIHR EME grant number 14/23/26 provided financial support to the organizations employing the co-authors except Mr. Boucher. Drs. Lambert, Coulthard, Holstein, Crosier, Duncan, Grant, Mok, Ghose, McColl, A. Steel, Smith, Whitaker, Wilson, and Wirz received support for article research from the NIHR EME. Drs. Lambert, Coulthard, Holstein, Agbeko, Duncan, Mok, Pappachan, Chisholm, Ghose, McColl, Parslow, Pattinson, A. Steel, Straker, Walker, Whitaker, Wightman, and Wood and Mr. Boucher disclosed the off-label product use of the Newcastle Infant Dialysis Ultrafiltration System (NIDUS) device. Dr. Coulthard disclosed that he is the inventor of the NIDUS device and is named on a patent submitted by Newcastle upon Tyne Hospitals NHS Trust. Dr. Coulthard has the possibility that he may receive royalties in the future from sales of the NIDUS. Mrs. Crosier disclosed the off-label product use of dialyzing babies less than 8 kg. Dr. McColl disclosed government work. Mr. Smith disclosed that he does medicolegal expert work in the field of pediatric anesthesia and PICU. Dr. Agbeko is editor for Archives of Disease in Childhood and received funding from BMJ Publishing. Dr. Lambert received Honorarium September 2022 for a case study presentation (not I-KID) at transplant educational event by Sandoz. Dr. Straker has medicolegal reports for court: none related to the area of pediatric dialysis/or dialysis devices and was the honorary treasurer of the European Extracorporeal Life Support Organisation until 2021. The remaining authors have disclosed that they do not have any potential conflicts of interest.
(Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.)