Low-Dose Albumin Infusion for the Prevention of Paracentesis Induced Circulatory Dysfunction (PICD), After Large Volume Paracentesis in Decompensated Cirrhosis of Liver.

Detailed Summary

Abstract for thesis protocol. Background: Paracentesis induced circulatory dysfunction (PICD) is a common complication of large volume paracentesis in cirrhotic patients, which can lead to renal impairment, hyponatremia, and increased mortality. Albumin infusion is recommended to prevent PICD, but the optimal dose is unclear. We aim to compare the efficacy of low dose albumin infusion versus standard dose of albumin in preventing PICD in cirrhotic patients. Material and methods: We will conduct a randomized controlled trial with two arms: low dose albumin infusion (2g per liter of ascitic fluid removed) versus standard dose albumin infusion (6g per liter of ascitic fluid removed). Patients with liver cirrhosis undergoing large volume paracentesis (\>5 L) with serum creatinine \<1.5 mg/dL and no signs of infection will be included in the study. Sample size calculation: Based on previous studies, group sample size will be 26 and will achieve 80.749% power to reject null hypothesis. As per availability, 30 participants will be included in each group, with a total number of 60 for this trial. Outcome of the study: The primary outcome is the incidence of paracentesis induced circulatory dysfunction (PICD) in both groups, (Low dose albumin and standard dose of albumin), 7 days after paracentesis. The secondary outcomes are renal failure, hyponatremia, hepatic encephalopathy, hepatorenal syndrome, and length of hospital stay. Conclusion: This trial will provide evidence on whether low dose albumin infusion is as effective as standard dose albumin infusion in preventing PICD in cirrhotic patients. This could have implications for reducing the cost and optimal effective dose of albumin therapy, as well as improving the outcomes of patients with ascites.

Study Details

Timeline

Interventions