Kidney transplantation in paediatric patients with end-stage kidney disease MedDRA version: 20.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865 MedDRA version: 21.1 Level: LLT Classification code 10014647 Term: End stage renal failure System Organ Class: 100000004857
Conditions
Interventions
Trade Name: Plasma-Lyte 148
Product Name: Plasma-Lyte 148
Product Code: N/A
Pharmaceutical Form: Solution for injection/infusion
Trade Name: Plasma-Lyte 148 & Glucose 5% w/v
Product Name: Plasma-Lyte
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children expected to be under 18 years of age at the time of transplantation 2. Children undergoing preparation for living or deceased donor kidney only transplantation, or active on the deceased donor transplant waiting list for a kidney only transplant at participating UK paediatric transplant centres either pre-emptively (not currently receiving dialysis) or patients on dialysis Are the trial subjects under 18? yes Number of subjects for this age range: 144 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Multi-organ transplant recipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The PLUTO trial will determine whether the incidence of abnormal and dangerous bloodstream electrolyte levels in paediatric kidney transplant recipients will be different with the use of PlasmaLyte-148 compared to intravenous fluid with current standard composition.;Secondary Objective: Secondary objectives of the PLUTO trial are to determine if the following complications will be different with the use of PlasmaLyte-148 compared to intravenous fluid with current standard composition: - Unpleasant symptoms such as nausea, vomiting, headache - Fits (seizures) - Fluid overload in the patient's body - Time to discharge from hospital - High blood sugar levels - Transplant kidney function;Primary end point(s): Acute hyponatraemia in the first 72 hours post-transplant (defined as plasma sodium concentration < 135mmol/l);Timepoint(s) of evaluation of this end point: First 72 hours post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Symptoms of acute hyponatraemia (nausea, vomiting, headache, seizures) within the first 72 hours post-transplant • The degree of fluid overload experienced (defined as proportional increase in patient weight between pre-transplant weight and maximum weight in 72 hours post-transplant weight) • Time to discharge from hospital (measured from transplant operation start time (“knife to skin”)) measured in days • Transplant kidney function at 1, 3, 7 and 90 days (determine by creatinine and height at transplant to determine eGFR) • Other electrolyte abnormalities within the first 72 hours post transplantation: o Hypernatraemia (defined as plasma sodium concentration > 145mmol/l) o hyperkalaemia (defined as plasma potassium concentration > 5.5mmol/L) o hypokalaemia (defined as plasma potassium concentration 5.5 mmol/L) o hypomagnesaemia (defined as plasma magnesium concentration 107mmol/L) o excessive rate of reduction in plasma sodium concentration (defined as >1mmol/L/hour averaged over 6 hours) o excessive magnitude of reduction in plasma sodium concentration (defined as > 10mmol/L from pre-transplant level) • Maximum systolic blood pressure (normalised to age and height percentile) sustained on 3 repeated values on each day, for 3 days post-transplant | — |
Countries
United Kingdom
Contacts
Public ContactEmma Laing
NHS Blood and Transplant
Outcome results
None listed