Abstract: FR-PO0122
Association of Paracentesis with Hepatorenal Syndrome (HRS) Reversal: Insights from the CONFIRM Trial of Terlipressin (Terli)
Session Information
- AKI: Epidemiology and Clinical Trials
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Patidar, Kavish Rohit, Houston Methodist Hospital, Houston, Texas, United States
- Allegretti, Andrew S., Massachusetts General Hospital, Boston, Massachusetts, United States
- Cullaro, Giuseppe, Columbia University, New York, New York, United States
- Jalal, Prasun K, Baylor College of Medicine, Houston, Texas, United States
- Cardoza, Sanaz, Mallinckrodt Pharmaceuticals, Bridgewater, New Jersey, United States
- Wu, Richard, Mallinckrodt Pharmaceuticals, Bridgewater, New Jersey, United States
- Velez, Juan Carlos Q., Ochsner Health, New Orleans, Louisiana, United States
Background
HRS-acute kidney injury (AKI) is a potentially reversible, life-threatening condition that arises as a complication of liver cirrhosis with ascites. Terli is the standard-of-care for adult patients (pts) with HRS-AKI to reverse HRS and improve kidney function. While relieving intra-abdominal pressure via paracentesis may improve renal hemodynamics, the procedure may worsen effective hypovolemia and renal perfusion. We assessed the impact of paracentesis on HRS reversal in pts with HRS-AKI treated with terli or placebo (pbo).
Methods
In this post hoc analysis of a Phase III randomized controlled trial (CONFIRM, NCT02770716) in pts with HRS-AKI treated with terli or pbo, we examined the effect of paracentesis on HRS reversal (ie, ≥1 serum creatinine [SCr] value ≤1.5mg/dL while on treatment [tx] ≤24h after the last dose of study drug). We recorded paracentesis from tx initiation up to 14 days or until HRS reversal (primary outcome), whichever came first. Multivariable (MV) logistic regression analysis evaluated the independent association of paracentesis with outcomes.
Results
Among 300 pts (terli, n=199; pbo, n=101), 93 (31%) underwent paracentesis. Median (IQR) paracentesis events for both terli (n=59) and pbo (n=34) was 1 (1–1) events; volume removed was 4 (2–6) L for terli vs 4 (3–8) L for pbo. Mean changes in SCr were significantly lower after paracentesis (P<.001; Figure). In MV analysis, postbaseline paracentesis was associated with higher odds of HRS reversal (1 event: OR 2.73, 95% CI 1.46–5.11, P=.002; ≥2 events: OR 3.58, 95% CI 1.26–10.20, P=.017). Other independent factors associated with HRS reversal were SCr (OR 0.39, 95% CI 0.27–0.56, P<.001) and terli tx (OR 3.45, CI 1.80–6.63, P<.001).
Conclusion
In pts with HRS-AKI, paracentesis was associated with increased odds of HRS reversal and a statistically significant decrease in SCr over 72h.
Funding
- Commercial Support – Mallinckrodt Pharmaceuticals