Randomized cross-over comparison of double mini PET test
Research type
Research Study
Full title
Randomized cross-over comparison of double mini Peritoneal Equilibration Test (PET) with standard vs adapted dwell volume and dwell time Proof of concept of adapted PD
IRAS ID
196042
Contact name
Rukshana shroff
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Adults and children with severe kidney failure are managed with dialysis. Dialysis is of two types – peritoneal dialysis (PD) and haemodialysis. PD uses the patient’s own peritoneum (tummy lining) as a filter to exchange fluids and remove toxins. PD involves instilling dialysis fluid into the abdomen (called fill volume) for a period of time (called dwell time) and then draining it out; multiple cycles of fill – dwell – drain are performed through the course of a single daily PD treatment, and all of these steps are performed by special PD machines. The efficacy of our current PD treatment is limited by the PD machines that only deliver fixed fill volumes and dwell times without allowing any variation between cycles.
New PD machines that can vary the fill volume and dwell time for each PD cycle are available and routinely used for adults and children across the EU. This allows the physician to adapt the PD programme to an individual patients’ needs and is called adapted PD. A recent multi-center trial in adults suggests that an adapted PD regimen consisting of a sequence of short-small dwells followed by large-long dwell (using the same amount of dialysate in the same total treatment time) substantially improves fluid and toxin removal. Adapted PD in used in children but effects are not studied.
We will compare clearances on conventional and adapted PD using the Peritoneal Equilibration Test (PET). The PET test is routinely performed in children 6-monthly (as day-case assessment) to analyse peritoneal transport function. We will use the well validated method of a modified double mini PET in random sequence to compare conventional and adapted PD cycles. Fifteen stable paediatric PD patients treated in four European dialysis centres will be recruited with full ethical permission to study time and volume dependent PD transport mechanisms.
REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/1223
Date of REC Opinion
3 Aug 2016
REC opinion
Further Information Favourable Opinion