{
  "abstract": "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/m 2/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.",
  "authors": [
    {
      "affiliations": [
        "Centre for Bladder and Kidney Health, University College London, London, UK"
      ],
      "name": "Nuala D M Calder"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "Fotini Kaloyirou"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "James Griffiths"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "Rosie Brown"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "Cara Hudson"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "Rupa Sharma"
    },
    {
      "affiliations": [
        "Department of Women's and Children’s Health, University of Liverpool, Liverpool, UK"
      ],
      "name": "Hayley Hardwick"
    },
    {
      "affiliations": [
        "Centre for Bladder and Kidney Health, University College London, London, UK",
        "Department of Women's and Children’s Health, University of Liverpool, Liverpool, UK"
      ],
      "name": "Lousie Oni"
    },
    {
      "affiliations": [
        "Department of Nephrology and Transplantation, Guy’s Hospital, London, UK"
      ],
      "name": "Chris Callaghan"
    },
    {
      "affiliations": [
        "School of Health and Health Related Research, University of Sheffield School of Health and Related Research, Sheffield, UK"
      ],
      "name": "Matt Stevenson"
    },
    {
      "affiliations": [
        "Department of Nephrology, Royal Manchester Children’s Hospital, Manchester, UK"
      ],
      "name": "Mohan Shenoy"
    },
    {
      "affiliations": [
        "Department of Nephrology, Royal Hospital for Children, Glasgow, UK"
      ],
      "name": "Ben Reynolds"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Great Ormond Street Hospital For Children NHS Trust, London, UK",
        "NIHR Biomedical Research Centre, University College London Great Ormond Street Institute of Child Health, London, UK"
      ],
      "name": "Stephen Marks"
    },
    {
      "affiliations": [
        "Department of Psychology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK"
      ],
      "name": "Jo Wray"
    },
    {
      "affiliations": [
        "NHS Blood and Transplant Clinical Trials Unit, Cambridge, UK"
      ],
      "name": "Helen Thomas"
    },
    {
      "affiliations": [
        "Paediatric Intensive Care Unit, Great Ormond Street Hospital For Children NHS Trust, London, UK"
      ],
      "name": "Mark J Peters"
    },
    {
      "affiliations": [
        "Department of Paediatric Nephrology, Great Ormond Street Hospital For Children NHS Trust, London, UK",
        "Department of Nephrology, Zurich Childrens Hospital, Zurich, Switzerland"
      ],
      "name": "Wesley Hayes"
    }
  ],
  "title": "Randomised multiple centre trial of conservative versus liberal fluid administration for children receiving a kidney transplant (LIMITS): clinical trial protocol",
  "uid": "5f42f7cc-c0b0-5c72-b2a3-1cf21f1ee6b5"
}