Iron-chelator added to dialysis fluid in sepsis-related AKI on CRRT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, two-period crossover study in the ICU of Nîmes University Hospital. Adults with sepsis-associated AKI needing continuous renal replacement therapy will receive two consecutive 24-hour dialysis sessions: one with standard dialysate and one with dialysate containing the iron chelator MEX-CD1, serving as their own control. The trial measures iron removal in dialysis effluent, blood iron levels, and markers of inflammation and oxidative stress, along with safety outcomes up to 28 days. The goal is to determine if adding MEX-CD1 to the dialysis fluid increases iron clearance without causing unacceptable safety issues. It is a Phase I-II pilot study designed to explore a novel approach to managing labile iron during CRRT in sepsis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Known shellfish allergy
* Moribund status with life expectancy too low to benefit
* Concurrent participation in another interventional study
* Exclusion period defined by another study
* Under legal protection (guardianship or curatorship)
* Inability to obtain informed consent from patient or representative
* Pregnant, parturient, or breastfeeding women

Where it's running

• CHU de Nîmes
  Nîmes, France Recruiting
• Nimes University Hospital
  Nîmes, Gard, France Not yet recruiting

Study contacts

• Principal investigator: Saber D BARBAR, MD, PhD — Centre Hospitalier Universitaire de Nīmes
• Study coordinator: Saber D BARBAR, MD, PhD
• Email: saber.barbar@chu-nimes.fr
• Phone: 0033466683320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.