Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Refractory Cirrhotic Ascites and Diabetes: Scoping Review Protocol.

Background: Hepatic cirrhosis is a complex condition leading to multiple complications, including ascites, hepatic encephalopathy, bleeding varices, and eventually liver failure. Patients with diabetes mellitus or insulin resistance are more likely to fail treatment, leading to the worsening of hepatic fibrosis. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a new class of drugs with the potential for use in cirrhotic ascites. This scoping review will focus on the response of the addition of SGLT2 inhibitors (SGLT2i) on refractory ascites. Objective: The objective of this scoping review is to understand the extent and type of evidence in relation to the response of the addition of SGLT2i on refractory ascites in patients with diabetes mellitus or insulin resistance. Methods: A comprehensive literature search will be conducted across five databases using variations of the keywords "Sodium-glucose Cotransporter-2 Inhibitors" and "ascites" to identify original studies published from inception through December 2023. The search will be limited to English-language human studies evaluating the efficacy of SGLT2 inhibitors, excluding studies focused on other drugs or conducted in animal models. This review will include studies involving patients over 21 years of age with cirrhotic ascites and will exclude studies involving noncirrhotic causes. Only studies containing original patient data will be considered, regardless of health care setting, to ensure clinical relevance and consistency in interpretation. Results: The results of this scoping review will offer a comprehensive overview of the available evidence on the use of SGLT2i in the management of cirrhotic ascites. This review will summarize key study characteristics, patient populations, interventions, and outcomes, and identify existing knowledge gaps and research priorities. Findings will be presented narratively and in tabular format to facilitate interpretation and comparison. The review process began with protocol development and registration in February 2025. A structured literature search and database screening will follow, continuing through June. Title and abstract screening, along with full-text review and eligibility assessment, will be completed by July 2025. Data extraction and charting will take place in July, with synthesis and analysis of findings occurring through August. Manuscript drafting will begin in August, and the final review and submission of the completed scoping review are anticipated by September 2025. Conclusions: By systematically identifying and summarizing original studies that assess the efficacy of SGLT2i in this unique patient population, the review will provide insight into the therapeutic potential of this drug class beyond glycemic control. It will also highlight the strengths and limitations of the existing literature, identify key knowledge gaps, and suggest directions for future research. Ultimately, this review may support the rationale for further clinical investigation and the development of targeted therapies for a high-risk group of patients with limited treatment options.