Newcastle Clinical Trials Unit



I-KID - Infant Kidney Dialysis and filtration – Evaluation of Efficacy, Outcomes and Safety of a New Infant Haemodialysis and Ultrafiltration Machine in Clinical Use

Study stage: Analysis/Closedown
Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Funder: NIHR - Efficacy and Mechanism Evaluation Programme (EME)
Therapeutic area: Renal and Urogenital
Type of study: Clinical Investigation (non-CE Marked Device)

Aim: To compare the Newcastle Infant Dialysis Ultrafiltration (NIDUS) machine with the other existing renal replacement therapy methods (including Peritoneal Dialysis (PD), and Continuous Haemofiltration and Dialysis (CVVH-D)) in order to make recommendations about which machine should be used in the future for babies under 8kg. Conventional dialysis machines currently used in practice have been adapted from systems for larger babies and adults. The NIDUS has been designed especially for babies who weigh less than 8kgs who are receiving dialysis in PICU (Paediatric Intensive Care Unit).

Primary outcome: Accuracy of fluid removal compared with prescription – a measure that includes fluid removal prevision of the dialysis system (Does the dialysis methodology provide the hourly fluid removal that the clinical team wanted?).

Population: Paediatrics
Design: Stepped wedge
Setting: Secondary Care
Planned Sample Size: 95