Comparison of the efficacy and safety of nafamostat mesylate and heparin in blood purification therapy for patients with severe acute pancreatitis: protocol for a randomized controlled trial.

BACKGROUND: Blood purification plays an important role in the treatment of severe acute pancreatitis. Extracorporeal blood anticoagulation is an important strategy to achieve smooth circulation in blood purification circuits. We aimed to investigate the efficacy, safety, and impact on circulating cytokines of using heparin or nafamostat mesylate anticoagulation in patients with severe acute pancreatitis during continuous renal replacement therapy. METHODS AND ANALYSIS: This is a single-center randomized controlled study. We plan to recruit adult patients with severe acute pancreatitis from intensive care units for this study. Participants who met the criteria were randomly assigned in a 1:1 ratio, with one group using heparin anticoagulation during continuous renal replacement therapy and the other group using nafamostat mesylate anticoagulation. The primary outcome measure was mean filter life. Secondary outcome measures included changes in Sequential Organ Failure Assessment (SOFA), the Acute Physiology and Chronic Health Evaluation II (APACHE II) score, and inflammatory factors (CRP, PCT, IL-6, IL-8, IL-10, TNF-α) compared with baseline levels on days 1, 3, 5, and 7 after treatment, time to successful initiation of enteral nutrition, blood transfusion requirements, ICU length of stay and total hospitalization days, and follow-up of patients' blood purification dependency rate and all-cause mortality at 28 days. Safety indicators include the occurrence of any bleeding events (defined by ISTH criteria), filter clotting, and the incidence of heparin-induced thrombocytopenia. DISCUSSION: The results of this study are expected to provide guidance for the selection of anticoagulant drugs for critically ill patients with severe acute pancreatitis who receive continuous renal replacement Therapy, and to clarify the optimal anticoagulation strategy for this population, thereby optimizing clinical practice for treating SAP patients. CLINICAL TRIAL REGISTRATION: [https://clinicaltrials.gov/], identifier [ChiCTR2500 111161].