PlasmaLyte Usage and assessment of kidney Transplant Outcomes in children: the PLUTO trial

Phase 1

Conditions: Kidney transplantation in paediatric patients with end-stage kidney disease
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865
MedDRA version: 21.1Level: LLTClassification code 10014647Term: End stage renal failureSystem Organ Class: 100000004857

Registration Number: EUCTR2019-003025-22-GB

Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 144

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

1.Multi-organ transplant recipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br> - Unpleasant symptoms such as nausea, vomiting, headache<br> - Fits (seizures)<br> - Fluid overload in the patient's body<br> - Time to discharge from hospital<br> - High blood sugar levels<br> - 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 Outcome Measures