Efficacy and safety of haemadsorption combined with continuous renal replacement therapy for rhabdomyolysis and acute kidney injury: a single-center, open-label, randomised controlled trial protocol.

INTRODUCTION: Myoglobin (Mb) exerts both direct and indirect nephrotoxic effects, contributing to the progression of kidney injury. For patients with rhabdomyolysis (RM) and acute kidney injury (AKI) requiring renal replacement therapy (RRT), Mb clearance is a critical therapeutic goal. Recent studies have indicated that haemoadsorption (HA) combined with continuous renal replacement therapy (CRRT) is an effective strategy for removing circulating Mb. However, clinical data regarding the efficiency of Mb clearance and long-term patient outcomes with this approach remain limited. This study aims to evaluate the efficacy and safety of HA combined with CRRT in treating severe RM and AKI. METHODS AND ANALYSIS: This single-center, open-label, randomised controlled trial will be conducted at West China Hospital of Sichuan University. A total of 60 patients with severe RM and AKI will be enrolled and randomly assigned in a 1:1 ratio to either the CRRT group or the CRRT+HA group. Randomisation will be conducted by drawing lots, performed by the patient's legal representative (with '0' indicating the CRRT group and '1' indicating the CRRT+HA group).The primary outcome of the study is the plasma clearance of Mb. Secondary outcomes include the plasma clearance of creatine kinase, haemodynamic changes, changes in acute physiology and chronic health II (APACHE) II score and sequential organ failure assessment (SOFA) score, renal function recovery, length of hospital stay, all-cause mortality, and pre- and post-treatment changes in albumin, platelet and haemoglobin counts. Data will be analysed using both intention-to-treat and per-protocol analysis methods. ETHICS AND DISSEMINATION: The study will comply with the Declaration of Helsinki and the Chinese Clinical Trials Act. The study protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (2024.1914). Written informed consent will be obtained from all participants. The study results will be presented at academic meetings and in peer-reviewed academic journals. TRIAL REGISTRATION NUMBER: ChiCTR2400092176.