New Miniaturized System for Ultrafiltration: Rationale and Design of a Single-Center, Crossover, Randomized, Open-Label, Pilot Study Protocol

Cardiorenal medicine

article

Reis, Thiago¹  Sgarabotto, Luca³  Brendolan, Alessandra³  Lorenzin, Anna³  Corradi, Valentina³  Marchionna, Nicola³  Zanella, Monica³  Ronco, Claudio³ 

[1] D’Or Institute for Research and Education ,(IDOR), São Luiz Itaim Hospital;Laboratory of Molecular Pharmacology, Faculty of Health Sciences, University of Brasília;International Renal Research Institute of Vicenza;Department of Nephrology, Dialysis and Kidney Transplantation, San Bortolo Hospital;Department of Medicine ,(DIMED), Università Degli Studi di Padova

关键词: Ultrafiltration;    Artificial diuresis;    Wearable;    Portable;    Miniaturization;    Heart failure;    Fluid overload;   

DOI  :  10.1159/000530943

学科分类：心脏病和心血管学

来源: S Karger AG

【 摘 要 】

Introduction: Fluid overload and congestion are common features in patients with heart failure and are associated with negative clinical outcomes. Therapies for these conditions are diuretic-centered but frequently fail to achieve patient-adequate hydration status, prompting the use of extracorporeal ultrafiltration. Artificial Diuresis 1 (AD1) is a miniaturized, portable, and wearable system designed to deliver isolated ultrafiltration with the finest degree of simplicity and practicality. Methods/Design: Single-center, crossover, randomized, open-label pilot study to investigate the safety and the efficacy (concerning ultrafiltration accuracy) of extracorporeal ultrafiltration with the device AD1 in comparison to isolated ultrafiltration with a traditional machine (PrisMaX). Patients with chronic kidney disease stage 5D (on hemodialysis) or intensive care patients presenting acute kidney injury stage 3D (requiring hemodialysis) will carry out a single session of isolated ultrafiltration with each of the machines. The safety primary outcomes will be the occurrence of adverse events. The efficacy primary outcome will be the accuracy of ultrafiltration rate (delivered/prescribed) on each of the devices. Conclusion: AD1 is a novel miniaturized device for extracorporeal ultrafiltration. This study will be the first-in-human use of AD1 in patients with fluid overload.

【 授权许可】

CC BY