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

• Published in: The American journal of gastroenterology Vol. 119; no. 10; pp. 2045 - 2051
• Main Authors: Tanaka, Tomohiro, Vander Weg, Mark, Jones, Michael P., Wehby, George
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Wolters Kluwer 01.10.2024; Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subjects: Aged; Albumins - administration & dosage; Ascites; Ascites - etiology; Ascites - therapy; Bandwidths; Cholangitis; Clinical trials; Creatinine; Creatinine - blood; Disease management; Diuretics; Female; Gastroenterology; Hepatitis; Hepatology; Humans; Infusions, Intravenous; Liver cirrhosis; Liver Cirrhosis - complications; Liver diseases; Male; Middle Aged; Paracentesis - methods; Patients; Practice Guidelines as Topic; Proteins; Retrospective Studies; Sodium; Sodium - administration & dosage; Sodium - blood; Transplants & implants; Ultrasonic imaging; Therapeutic parenthesis; regression discontinuity; portal hypertension; causal inference; liver cirrhosis; albumin
• ISSN: 0002-9270; 1572-0241; 1572-0241
• DOI: 10.14309/ajg.0000000000002767

INTRODUCTION:The 2021 American Association for the Study of Liver Disease (AASLD) Practice Guidance recommends albumin infusion when removing ≥5 L 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 US 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 used a sharp regression discontinuity (RD) design to estimate the effect of albumin infusion at the AASLD Guidance-recommended cutoff of 5 L on serum creatinine and sodium trajectory after TP.RESULTS:Over the study period, 1,457 elective TPs were performed on 235 unique patients. Albumin infusion at the threshold of 5 L of ascites removal reduced serum creatinine levels by 0.046 mg/dL/d (95% confidence interval 0.003-0.116, P = 0.037) and increased serum sodium levels by 0.35 mEq/L/d (95% confidence interval 0.15-0.55, P = 0.001) compared with those who did not receive albumin infusion. The RD plots indicated worsened serum creatine/sodium levels after draining 3 L of fluid, approaching levels similar to or worse than with albumin infusion at 5 L or more.DISCUSSION:Our RD models supported the 2021 AASLD Guidance with robust estimation of causal effect sizes at the cutoff level of 5 L. 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 L of ascites removed.