{
  "abstract": "Introduction Sepsis-associated acute kidney injury is common in intensive care and is linked to high morbidity and mortality, yet no specific therapy exists beyond supportive care. Excess circulating labile iron contributes to oxidative stress, mitochondrial dysfunction and cell death via ferroptosis. We hypothesise that targeted removal of labile iron during dialysis may reduce this pathogenic process. This study will evaluate the performance and safety of adding a novel iron chelator named MEX-CD1 (Metal EXtraction - Chitosan DOTAGA 1) to dialysate during continuous veno-venous haemodialysis (CVVHD) in critically ill patients with sepsis-associated acute kidney injury.Methods and analysis This is a single-centre, randomised, open-label, crossover phase I–II pilot study in the intensive care unit of Nîmes University Hospital, France. 14 adult patients with sepsis-associated acute kidney injury requiring renal replacement therapy will receive two consecutive 24-hour CVVHD sessions: one with standard dialysate and one with dialysate supplemented with MEX-CD1 at 50 mg/L. Each patient serves as their own control. The primary outcome is the iron concentration in the effluent to measure iron removal performance. Secondary outcomes include plasma iron clearance, trace element loss, biomarkers of oxidative stress and inflammation, and safety outcomes monitored up to 28 days. Statistical analyses will use paired tests and mixed linear regression models.Ethics and dissemination Ethical approval has been obtained from the Comité de Protection des Personnes (no. 25.01220.000448) and the French National Agency for Safety of Drugs and Medical Devices (no. 2024-A01530-47). Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT07236463.",
  "authors": [
    {
      "affiliations": [
        "Department of Nephrology, American Hospital of Paris, Neuilly-sur-Seine, France",
        "Pulmonary and Cardiovascular Aggression in Sepsis APCSe, UPSP 2021.A101, VetAgro Sup, Campus Vétérinaire de Lyon, Université de Lyon, Marcy L’Etoile, France"
      ],
      "name": "Aymeric Couturier"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, University of Montpellier, Nîmes University Hospital, Nimes, France"
      ],
      "name": "Chris Serrand"
    },
    {
      "affiliations": [
        "Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology, University of Montpellier, Nîmes University Hospital, Nimes, France"
      ],
      "name": "Christophe Masseguin"
    },
    {
      "affiliations": [
        "Critical Care, Hospices Civils de Lyon, Pierre-Bénite, France"
      ],
      "name": "Bernard Allaouchiche"
    },
    {
      "affiliations": [
        "Institute Light and Mater, UMR5306, Lyon1 University-CNRS, Lyon, France"
      ],
      "name": "Olivier Tillement"
    },
    {
      "affiliations": [
        "Research Unit UR‑UM103 IMAGINE, University of Montpellier, Department of Anesthesia, Critical Care, Pain Medicine, and Emergency Medicine, Nîmes University Hospital, Nimes, France"
      ],
      "name": "Jean-Yves Lefrant"
    },
    {
      "affiliations": [
        "Research Unit UR‑UM103 IMAGINE, University of Montpellier, Department of Anesthesia, Critical Care, Pain Medicine, and Emergency Medicine, Nîmes University Hospital, Nimes, France",
        "Intensive Care Unit, Department of Anesthesia, Critical Care, Pain Medicine, and Emergency Medicine, University Hospital Centre Nîmes Division of Anaesthesiology Intensive Care Pain Medicine and Emergencies, Nimes, Occitanie, France"
      ],
      "name": "Saber Davide Barbar"
    }
  ],
  "title": "Evaluation of the performance and safety of adding the iron chelator MEX-CD1 to dialysate during continuous veno-venous haemodialysis for removing excess labile iron in intensive care patients with sepsis-associated acute kidney injury - the Iron in Intensive Care trial (IRON-I.C.): protocol for a phase I–II randomised crossover pilot study",
  "uid": "003710b5-3226-53bd-823f-ad260e213cc4"
}