Assessment of the 2021 AASLD Practice Guidance for Albumin Infusion in Elective Therapeutic Paracentesis: A Regression Discontinuity Design.

BACKGROUND: The 2021 American Association for the Study of Liver Disease (AASLD) Practice Guidance recommends albumin infusion when removing ≥ 5 liters of ascites to prevent post-paracentesis circulatory dysfunction. However, the optimal criteria and scenarios for initiating albumin infusion subsequent to therapeutic paracentesis (TP) have been subject to limited scientific inquiry.

METHODS: We conducted a retrospective cohort study at a U.S. academic healthcare center. Participants received elective, outpatient TP between July 2019 and December 2022. Patients with spontaneous bacterial peritonitis, post-TP clinical adjustments, and/or hospitalization were excluded. The institution strictly followed the AASLD Guidance. We employed a sharp regression discontinuity (RD) design to estimate the effect of albumin infusion at the AASLD Guidance-recommended cutoff of 5 liters on serum creatinine and sodium trajectory post-TP.

RESULTS: Over the study period, 1457 elective TPs were performed on 235 unique patients. Albumin infusion at the threshold of 5 liters of ascites removal reduced serum creatinine levels by 0.046 mg/dl/day (95% CI: 0.003 to 0.116, p-value=0.037) and increased serum sodium levels by 0.35 mEq/L/day (95% CI: 0.15-0.55, p=0.001) compared to those who did not receive albumin infusion. The RD plots indicated worsened serum creatine/sodium levels after draining 3 liters of fluid, approaching levels similar to or worse than with albumin infusion at 5 liters or more.

CONCLUSIONS: Our RD models supported the 2021 AASLD Guidance with robust estimation of causal effect sizes at the cutoff level of 5 liters. Nevertheless, the findings also highlight the need to further evaluate the efficacy of albumin infusion in patients who undergo elective TP and have 3-5 liters of ascites removed.