Performance and Safety of Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate During Continuous Veno-venous Hemodialysis for Sepsis-associated AKI: Protocol for a Phase I-II Randomized Crossover Pilot Study.
The goal of this clinical trial is to learn if adding the iron-binding drug MEX-CD1 to dialysis fluid can help remove excess iron in adults with sepsis-associated acute kidney injury (AKI) requiring dialysis who are in the intensive care unit (ICU). The main questions it aims to answer are: Does adding MEX-CD1 to the dialysis fluid increase the amount of iron removed during dialysis? Is using MEX-CD1 in dialysis fluid safe for patients? Participants will: Be adults in the ICU with sepsis-associated AKI who need continuous dialysis (renal replacement therapy) Receive two 24-hour dialysis sessions: one with standard dialysis fluid and one with dialysis fluid containing MEX-CD1 Serve as their own control, meaning they will receive both treatments Researchers will measure: The amount of iron removed in the dialysis waste fluid (primary outcome) Blood levels of iron Changes in other trace elements Markers of inflammation and oxidative stress Safety outcomes up to 28 days after treatment This is a pilot study being done at a single hospital in France.
• Adult patients (≥18 years) admitted to ICU with sepsis-associated AKI requiring CRRT
• Sepsis defined according to SEPSIS-3 criteria (suspected/documented infection with organ dysfunction indicated by ≥2-point increase in SOFA \[Sequential Organ Failure Assessment\] score)
• AKI Stage 3 per KDIGO (Kidney Disease: Improving Global Outcomes) criteria: acute rise in serum creatinine ≥3 times baseline or serum creatinine ≥4 mg/dL or urine output \<0.3 mL/kg/h for ≥24 hours or anuria (urine output \<100ml) for ≥12 hours
• Indications for CRRT: refractory hyperkalemia (\>6 mmol/L) or refractory metabolic acidosis (pH \< 7.20) or acute pulmonary edema unresponsive to medical management or urine output \<0.3 ml/kg/hour or anuria (urine output \<100ml) persistent for 48 hours and refractory to medical treatment
• Informed consent obtained from patient or legal representative
• Affiliated with or beneficiary of a health insurance plan