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.

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 50mg/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.

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.

NCT07236463.

Brain and heart conditions are among the leading causes of illness and mortality in Canada. Heart failure is one of the fastest-growing cardiovascular conditions globally, with more than 100 000 Canadians diagnosed each year. Individuals with heart failure are at significantly increased risk of mental health challenges such as depression, anxiety and stress. However, healthcare services often remain siloed, treating physical and mental health separately. This complicates care for individuals with multiple chronic conditions. This multiyear study will adapt, test and accelerate changes to regional care delivery models in Eastern Ontario to optimise brain-heart health and generate knowledge to support the spread and scale of effective interventions that address community needs and priorities. We aim to: (1) identify resource gaps by mapping available services; (2) document strengths and challenges in care delivery; and (3) co-design, pilot test and evaluate an intervention developed based on the priority gap area(s) identified through objectives (1) and (2).

This community-based participatory action research study is led by a research coalition of patient and caregiver partners, care providers and leadership staff from two Ontario Health Teams. In Year 1, we will conduct asset mapping and community consultations with individuals living with heart failure, caregivers, care providers and service organisations to identify care gaps, strengths and opportunities for improvement around modifiable behavioural risk factors and brain-heart health. A scoping review will identify evidence-based strategies to address care gaps and inform the co-design of an intervention focused on supporting individuals with brain-heart interconnected conditions. In Year 2, we will co-design an intervention with community partners for implementation with clinical test sites. Year 3 will involve pilot testing the intervention and conducting outcome and process evaluations. This will inform future spread and scale of the intervention to other brain-heart conditions and new jurisdictions.

The study is approved by the Bruyère Health Research Ethics Board (M16-24-016). Findings will be disseminated through peer-reviewed publications, conference presentations and knowledge mobilisation activities such as social media, community events and local media outreach, as well as through dedicated engagement with Ontario Health partners and the Brain-Heart Interconnectome Network via retreats and collaborative forums.