{
  "abstract": "Introduction The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).Methods and analysis The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.Ethics and dissemination The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.Trial registration number clinicaltrials.gov ( NCT06021288).",
  "authors": [
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Christian Strauß"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Mahan Sadjadi"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Thilo von Groote"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Hendrik Booke"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Ludwig Maximilian Schöne"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Clara Hegner"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Carola Wempe"
    },
    {
      "affiliations": [
        "Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Muenster, Germany"
      ],
      "name": "Melanie Meersch"
    },
    {
      "affiliations": [
        "Westfälische Wilhelms-Universität Münster, Muenster, Germany"
      ],
      "name": "Joachim Gerss"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine, University Hospital Tuebingen, Tuebingen, Germany"
      ],
      "name": "Alice Bernard"
    },
    {
      "affiliations": [
        "University Hospital Tuebingen, Tuebingen, Germany"
      ],
      "name": "Helene Anna Haeberle"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Intensive Care Medicine, University Hospital Tuebingen, Tuebingen, Germany"
      ],
      "name": "Peter Rosenberger"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, Germany"
      ],
      "name": "Tim Rahmel"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, Germany"
      ],
      "name": "Matthias Unterberg"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, Germany"
      ],
      "name": "Michael Adamzik"
    },
    {
      "affiliations": [
        "Department of Anesthesiology and Operative Intensive Care, University Hospital Marburg, Marburg, UK"
      ],
      "name": "Christian Arndt"
    },
    {
      "affiliations": [
        "Anesthesiology & Intensive Care Medicine, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, Germany"
      ],
      "name": "Hinnerk Wulf"
    },
    {
      "affiliations": [
        "Department of Anaesthesia and Intensive Care, Azienda Ospedaliero Universitaria Careggi, Florence, Tuscany, Italy"
      ],
      "name": "Stefano Romagnoli"
    },
    {
      "affiliations": [
        "Intensive Care Unit and Regional ECMO Referral Centre, Azienda Ospedaliero Universitaria Careggi, Florence, Italy"
      ],
      "name": "Manuela Bonizzoli"
    },
    {
      "affiliations": [
        "Department of Anaesthesia and Intensive Care, University Hospital Careggi, Firenze, Italy"
      ],
      "name": "Raffaele Mandarano"
    },
    {
      "affiliations": [
        "Department of Nephrology, Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, Zagreb, Croatia"
      ],
      "name": "Vedran Premuzic"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of São Paulo School of Medicine, Sao Paulo, Brazil"
      ],
      "name": "Lucia Andrade"
    },
    {
      "affiliations": [
        "Division of Nephrology, University of São Paulo School of Medicine, Sao Paulo, Brazil"
      ],
      "name": "Igor Smolentzov"
    },
    {
      "affiliations": [
        "University of Alberta, Edmonton, Alberta, Canada"
      ],
      "name": "Sean M Bagshaw"
    },
    {
      "affiliations": [
        "Department of Medicine, San Diego Veterans Affairs Medical Center, San Diego, California, USA"
      ],
      "name": "Lakhmir Chawla"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, Germany"
      ],
      "name": "Alexander Zarbock"
    }
  ],
  "title": "Randomised controlled study investigating standard dose continuous renal replacement therapy (CRRT) versus low-dose CRRT in critically ill patients with acute kidney injury (AKI): study protocol for a prospective, randomised, controlled, international, multicentre trial (the ‘Ketzerei’ trial)",
  "uid": "4b65c8ca-2694-56c8-84e7-660a403892d0"
}