Impact on Delta SOFA score in sepsis- induced acute kidney injury: a comparative study of haemofilter efficacy in continuous renal replacement therapy

Abstract

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated response to infection and is a significant cause of mortality worldwide. In sepsis, acute kidney injury is a major factor contribuing to morbidity, resulting from inflammation and microcirculatory dysfunction. It is the most common cause of death from infection, especially if there is a lack of early detection and treatment. The management of sepsis-induced acute kidney injury is complex and involves measures to eliminate infection sources, targeted antibiotics, and intensive care interventions such as vasopressors, mechanical ventilation, and continuous renal replacement therapy. Despite the availability of various CRRT filters, such as the AN69ST or oXiris haemofilter, there is a lack of high-quality studies and clinical guidelines that demonstrate their superiority over one another. This knowledge gap has resulted in the absence of a standardized protocol for continuous renal replacement therapy using haemofilter that adsorbs inflammatory mediators in clinical practice. This study aims to address this critical gap of knowledge by comparing the reduction of the Sequential Organ Failure Assessment (SOFA) scores of conventional filters (AN69ST) and the oXiris haemofilter during continuous renal replacement therapy in sepsis-acute kidney injury patients. The secondary objectives are to compare the survival, the reduction of inflammatory mediators and lactate levels, and the number of days requiring vasoactive drugs, mechanical ventilation, and renal replacement therapy. This study is designed as a randomized, triple-blind, prospective, parallel groups and multicentric clinical trial that will be performed at the ICU of Hospital Universitari Doctor Josep Trueta (HUJT) and Hospital Santa Caterina (HSC). The target population of this clinical trial are adult pa-ents admiwed to the ICU with sepsis induced acute kidney injury who meet the diagnostic criteria for both sepsis and AKI (KDIGO criteria), and who requires continuous renal replacement therapy. 254 participants will be enrolled using a consecutive non-probabilistic sampling method and the time of recruitment will be 2 years. A first SOFA score will be measured and will be set as the SOFA score at admission. Additionally, we will measure the inflammatory mediators and lactate levels. Later, the patients enrolled on the clinical trial will be randomised in a 1:1 ratio into two groups: group A will be treated using conventional haemofilter during the continuous renal replacement therapy, and group B will be treated with oXiris haemofilter. At 24 and 72 hours we will measure again the SOFA score respectively (SOFA score 24h and 72h), inflammatory mediators and lactate levels. The major outcome variable will be the delta SOFA score (D-SOFA)