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.
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Lambert Heather, Hiu Shaun, Coulthard Malcolm G, Matthews John N S, Holstein Eva-Maria, Crosier Jean, Agbeko Rachel, Brick Thomas, Duncan Heather, Grant David, Mok Quen, Nyman Andrew Gustaf, Pappachan John, Boucher Chris, Bulmer Joe, Chisholm Denise, Cromie Kirsten, Emmet Victoria, Feltbower Richard G, Ghose Arunoday, Grayling Michael, Harrison Rebecca, Kennedy Ciara A, McColl Elaine, Morris Kevin, Norman Lee, Office Julie, Parslow Roger, Pattinson Christine, Sharma Shriya, Smith Jonathan, Steel Alison, Steel Rachel, Straker Jayne, Vrana Lamprini, Walker Jenn, Wellman Paul, Whitaker Mike, Wightman Jim, Wilson Nina, Wirz Lucy, Wood Ruth
Аннотация
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.