A trial examining if less fluid administration is better than standard fluid administration in children undergoing kidney transplant

A randomised multiple centre trial of conservative versus liberal fluid administration for children receiving a kidney transplant

Registry ID
ISRCTN21516608
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Enrollment
140
Start date
2025-10-23
Completion date
2027-12-31
Last update
2026-08-17

Conditions

Summary

Fluid management in paediatric kidney transplantation

Detailed description

Summary of treatment in each group: - Intervention: Fluid volume administration capped at maximum 150ml/m²/hour for no longer than 18 hours following transplant, reduced to a fixed daily target of maximum 1.5 litres/m²/day thereafter. No specific urine output will be targeted. No diuretics to be administered throughout. - Comparator: Target urine output >2ml/kg/hour. Fluid administered to replace urine output + insensible losses for at least 48 hours. Diuretics per the clinical team’s usual practice. Follow up period: Follow up data up will be collected up to 3 months post-transplant. Randomisation: Eligible patients who have consented to participate in LIMITS will be randomised via an interactive web response system, provided by Sealed Envelope. Participants will be randomised in a 1:1 ratio, to the intervention and comparator groups. The randomisation will be stratified by transplant centre and donor type (deceased vs. living donation). Randomisation will further be balanced within blocks of varying, undisclosed sizes.

Interventions

Inclusion criteria

1. Children under 18 years of age at the time of transplantation with valid informed consent 2. Children receiving a kidney only transplant from either a living or deceased donor, in a participating UK centre

Exclusion criteria

Multi-organ transplant recipients

Locations

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