BACKGROUND Ascites is the most common complication of cirrhosis.Current pharmacological interventions,such as diuretics,often become ineffective in advanced stages due to diuretic resistance.Sodium-glucose co-transpor...BACKGROUND Ascites is the most common complication of cirrhosis.Current pharmacological interventions,such as diuretics,often become ineffective in advanced stages due to diuretic resistance.Sodium-glucose co-transporter 2(SGLT2)inhibitors have demonstrated potential in enhancing urinary sodium excretion and mitigating sodium-fluid retention.This study aims to evaluate the effects of SGLT2 inhibitors on the fractional excretion of sodium(FENa)in patients with cirrhotic ascites.AIM To determine whether adjunctive therapy with the SGLT2 inhibitor empagliflozin increases FENa compared with standard care alone in patients with cirrhosis and refractory ascites,and to evaluate its short-term safety profile.METHODS The effect of SGLT2 inhibitor empagliflozin on FENa in patients with cirrhosis and refractory ascites is a multicenter,open-label,randomized controlled trial.A total of 70 patients with refractory ascites secondary to cirrhosis will be enrolled and randomly assigned to receive either empagliflozin 10 mg daily plus standard care or standard care alone for 14 consecutive days.The primary outcome is the change in FENa from baseline to day 14.Secondary outcomes include 24-hour urinary sodium excretion,urine volume,ascites volume(assessed by ultrasound),body weight,and safety indicators.Exploratory outcomes include changes in components of the reninangiotensin-aldosterone system.RESULTS This article reports the study protocol only.No participant data have been collected or analyzed for this manuscript.CONCLUSION This protocol evaluates whether empagliflozin,added to standard therapy,increases sodium excretion and reduces fluid overload in refractory ascites.展开更多
基金Supported by Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support,No.ZLRK202533High-Level Public Health Technology Talent Project,No.2022-2-005the Scientific Research Project of Beijing You’an Hospital,2024,No.BJYAYY-YN2022-20.
文摘BACKGROUND Ascites is the most common complication of cirrhosis.Current pharmacological interventions,such as diuretics,often become ineffective in advanced stages due to diuretic resistance.Sodium-glucose co-transporter 2(SGLT2)inhibitors have demonstrated potential in enhancing urinary sodium excretion and mitigating sodium-fluid retention.This study aims to evaluate the effects of SGLT2 inhibitors on the fractional excretion of sodium(FENa)in patients with cirrhotic ascites.AIM To determine whether adjunctive therapy with the SGLT2 inhibitor empagliflozin increases FENa compared with standard care alone in patients with cirrhosis and refractory ascites,and to evaluate its short-term safety profile.METHODS The effect of SGLT2 inhibitor empagliflozin on FENa in patients with cirrhosis and refractory ascites is a multicenter,open-label,randomized controlled trial.A total of 70 patients with refractory ascites secondary to cirrhosis will be enrolled and randomly assigned to receive either empagliflozin 10 mg daily plus standard care or standard care alone for 14 consecutive days.The primary outcome is the change in FENa from baseline to day 14.Secondary outcomes include 24-hour urinary sodium excretion,urine volume,ascites volume(assessed by ultrasound),body weight,and safety indicators.Exploratory outcomes include changes in components of the reninangiotensin-aldosterone system.RESULTS This article reports the study protocol only.No participant data have been collected or analyzed for this manuscript.CONCLUSION This protocol evaluates whether empagliflozin,added to standard therapy,increases sodium excretion and reduces fluid overload in refractory ascites.
