Early continuous renal replacement therapy versus standard care in critically ill children with septic shock: A pilot, single-centre, open-label, randomized controlled trial

Introduction: Reported mortality rates in patients with refractory septic shock are as high as 85%, making this a critical area for intervention. While CRRT is weakly recommended in paediatric septic shock with AKI for fluid balance management, its overall impact on outcomes remains unclear. CRRT may offer multiple benefits including clearance of inflammatory mediators, correcting coagulopathy, and managing metabolic disturbances and fluid balance, which could improve patient outcomes.

Primary Objective: To compare 28-day mortality in children with catecholamine-resistant septic shock receiving early CRRT compared with those receiving standard care.

 Methodology: This will be a pilot, single-centre, prospective, randomized, open-label, controlled trial. It will be conducted at PICU, AIIMS Raipur, India**.**Children aged 1 month-15 years with catecholamine-resistant septic shock (defined as VIS more than 15 for the purpose of the study), where endpoints of shock are not achieved or are in worsening trend despite 4 hours of adequate resuscitation, will be included in the study. These children should not have obstructive shock (cardiac tamponade, tension pneumothorax, massive pulmonary thrombo-embolism, elevated intra-abdominal pressure).  Children with anticipated PICU stay less than 24 hours, CPR before ICU admission, need of renal replacement therapy at PICU admission (as per conventional indications), known cases of autoimmune disease, cancer, chronic kidney disease, DCM, congenital heart disease, and those who did not give informed consent will be excluded from the study. Block randomization sequence will be computer generated. 60 patients will be randomly allocated in 1:1 ratio to 2 independent treatment groups using sealed envelope method: Group A (early CRRT + standard care) and Group B (standard care). Due to study design and intervention, blinding cannot be performed. For this study, CRRT will refer to CVVH and CVVHDF. Standard care will include fluid resuscitation, vasoactive and other organ support as per paediatric surviving sepsis guidelines with individualised targets. Antibiotic policy, source control, use of steroids and immunosuppressive therapy will be as per unit policy and same in both groups.

 Limitation and risks of the study: This will be pilot, single-centre, open label RCT with relatively small sample size. However, it will provide crucial preliminary safety and efficacy data to guide future large-scale trials. Patients in the intervention group will be exposed to CRRT related complications, and these adverse events will be rigorously monitored during the study.

Benefits of the study:This study is an attempt to explore mortality benefit of early CRRT in a subgroup of critically ill children with catecholamine resistant septic shock with high mortality rates.