Continuous home terlipressin infusion increases handgrip strength and reduces ascites – a prospective randomized cross-over study

Background & aims: Observational studies suggest a beneficial effect of continuous home terlipressin infusion (CTI) on ascites and sarcopenia in decompensated cirrhosis with portal hypertension. This is the first prospective randomized study of CTI in cirrhosis. Methods: This single-center, prospective, cross-over study randomized 30 patients with cirrhosis, ascites, and sarcopenia to commence on 12 weeks of home CTI or 12 weeks of observation prior to cross-over. The co-primary outcomes were change in handgrip strength and paracentesis volume. Secondary outcomes included quality of life, sarcopenia measures, renal function, safety and hospitalization. Results: The median age of participants was 62 years (IQR 57-64), median MELD-Na 16 (12.3-20.8) and 22 (73%) were male. Handgrip strength increased by a mean adjusted difference (MAD) of 3.09 kg (95% CI 1.11-5.08 kg) between CTI and observation ( p =0.006); an 11.8% increase from baseline. The total volume of ascites drained decreased by a MAD of 11.39L (2.99-19.85, p =0.01), with 1.75 fewer episodes of paracentesis (0.925-2.59, p <0.001) on CTI. Serum creatinine decreased, urinary sodium excretion increased, and quality of life was significantly higher on CTI (all p <0.001), with an increase in Chronic Liver Disease Questionnaire score of 0.41 points (0.23-0.59). There were seven minor line-related complications, but no cardiac events or pulmonary edema. Conclusion: This novel study demonstrates a significant increase in handgrip strength, reduction in paracentesis volume and improved quality of life in patients with decompensated cirrhosis treated with continuous terlipressin infusion. These findings provide a strong rationale for the use of ambulatory CTI in appropriately selected patients with cirrhosis.