I-KID: Infant KIdney Dialysis and filtration
Research type
Research Study
Full title
Evaluation of Efficacy, Outcomes and Safety of a New Infant Haemodialysis and Ultrafiltration Machine in Clinical Use.
IRAS ID
170481
Contact name
Heather Lambert
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 28 days
Research summary
Summary of Research
In more recent years an increasing number of babies are surviving very serious illness and complex surgical operations. Babies who are ill, and who may have had problems like bleeding or low blood pressure, often have problems with their kidney function and may stay longer in Paediatric Intensive Care Units (PICU). It may be so severe that the baby needs help with their kidney function by some form of Renal Replacement Therapy (RRT).There are several methods of RRT available for use in the NHS as part of standard care. Conventional methods include Peritoneal Dialysis (PD), and Continuous Haemofiltration and Dialysis (CVVH-D). Conventional machines are unlicensed as they are CE marked for use in adults and bigger children. The Newcastle Infant Dialysis Ultrafiltration System (Nidus) machine is the newest method and was developed in Newcastle upon Tyne. It has been designed especially for babies who weigh 7.99kg or less who are receiving dialysis in a PICU. The Nidus is currently a non CE marked device.
There is currently not enough data to say which RRT method provides the best support for small babies. This study is looking to compare the Nidus machine with the other existing RRT methods in order to make recommendations about which machine should be used in the future.
6 PICU’s across England have chosen to take part and offer the Nidus machine as one of their RRT methods during the intervention phase of this study. Each PICU will be randomised to a treatment sequence. Each sequence starts with conventional RRT (control phase), followed by training in the Nidus (training phase), and finally using the Nidus machine (intervention phase) in a stepwise manner. The length of time that the PICU spends in each phase will be different depending on the treatment sequence.
Summary of Results
Why do this study?
Some children in intensive care are so poorly that their kidneys do not work well, and they need help, called dialysis, to get rid of fluid and chemicals from their blood. For babies, we currently use peritoneal dialysis (PD), where fluid is cycled in and out of the tummy, or adapted machines designed for bigger children (CVVH). A new machine, the NIDUS®, was developed specifically for babies weighing under 8kg with much smaller tubing. NIDUS® worked well when studied in Newcastle but needed testing elsewhere.What was the question?
How well does NIDUS® work compared to other dialysis methods? What are the problems?What did we do?
The study was done in 6 PICUs who used their usual dialysis methods (= control) in the first part of the study and then later swapped to using the NIDUS® (= intervention).What did we find?
We recruited 97 participants, 62 to control (49 PD, 13 CVVH), and 35 intervention (NIDUS®). We found NIDUS® provided much better control of fluid removal. The CVVH machines were more efficient at blood cleaning than NIDUS®, which was better than PD.What does this mean?
We learnt a lot about babies needing kidney support in PICUs and that all methods have advantages and disadvantages. We showed that NIDUS® could be very useful for some participants because it cleans blood effectively and gives accurate, controllable fluid removal. We have gathered important information to help us improve NIDUS® to make it easier to use and run. Many parents responded to our questionnaire and most told us they felt it was acceptable to be approached about taking part in research despite the circumstances. This is very important for future research studies.
We are very grateful to families for their generosity in becoming involved in this study.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0008
Date of REC Opinion
8 Feb 2016
REC opinion
Favourable Opinion