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Randomised multiple centre trial of conservative versus liberal fluid administration for children receiving a kidney
Nuala D M Calder1, Fotini Kaloyirou2, James Griffiths2
1Centre for Bladder and Kidney Health, University College London, London, UK.
Insights
This study compares conservative versus liberal fluid administration in children after kidney transplants. The goal is to determine if limiting fluids improves outcomes, focusing on days at home post-transplant.
Area of Science:
- Nephrology
- Pediatric Transplant Surgery
- Critical Care Medicine
Background:
- Fluid administration protocols post-pediatric kidney transplant lack evidence-based guidelines.
- Current practices lead to significant fluid overload complications in up to 52% of pediatric transplant recipients.
- The optimal fluid management strategy for children undergoing kidney transplantation remains unknown.
Purpose of the Study:
- To determine if a conservative fluid administration strategy is superior to a liberal strategy in pediatric kidney transplant recipients.
- To assess the impact of fluid management on key outcomes in children post-kidney transplant.
- To provide evidence-based recommendations for fluid administration in this vulnerable population.
Main Methods:
- A pragmatic, open-label, multicentre randomised controlled trial (LIMITS) involving 140 children.
- Randomization to either conservative (max 150 mL/m²/hour for 18 hours, then 1.5 L/m²/day) or liberal fluid administration (urine output replacement + insensible losses).
- Primary outcome: mean days at home in the first 30 days post-transplant, analyzed via mixed linear regression.
Main Results:
- Primary outcome data collection is ongoing.
- The study is powered to detect significant differences in days at home.
- Cost-effectiveness analysis will be integrated.
Conclusions:
- The LIMITS trial will establish evidence-based fluid management guidelines for pediatric kidney transplant recipients.
- Findings are expected to reduce fluid overload complications and improve patient recovery.
- The study aims to optimize post-transplant care and long-term outcomes for children.
Introduction:
In current practice, fluid volumes administered to children following kidney transplant vary widely. Up to 52% of children experience fluid overload-related complications. Current fluid guidelines are not evidence-based and the optimal amount of fluid for children after transplant is not known. The aim of Randomised multiple centre trial of conservative versus LIberal fluid adMInisTration for children receiving a kidney tranSplant (LIMITS) is to determine whether relative limitation of fluid volume administered to children receiving kidney transplants is superior to liberal fluid volume administration.
Methods And Analysis:
LIMITS is a pragmatic, open-label, UK-based, multicentre randomised controlled trial, with an internal pilot phase and integrated economic evaluation. A total of 140 children receiving kidney transplants will be randomised to receive either conservative postoperative fluid administration (maximum of 150 mL/m2/hour for no longer than 18 hours, followed by a fixed daily target of maximum 1.5 L/m2/day thereafter) versus the comparator of liberal postoperative fluid administration (fluid volume administered to replace urine output and insensible losses for at least 48 hours with target urine output >2 mL/kg/hour). The primary outcome is mean days at home in the first 30 days after kidney transplant. The primary outcome will be analysed using a mixed linear regression model adjusted for donor type (living vs deceased donor) and participant weight (<20 kg and ≥20 kg pretransplant) as fixed effects and transplant centre as a random effect. Cost-effectiveness will also be evaluated.
Ethics And Dissemination:
The trial received Health Research Authority approval on 20 August 2025 (REC reference: 25/EE/0161, IRAS project ID: 354370). Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain.
Trial Registration Number:
ISRCTN21516608.
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