» Articles » PMID: 39980577

Comparative Study of Terlipressin and Noradrenaline As Vasopressors in Patients With Acute-on-chronic Liver Failure and Septic Shock: A Randomized Controlled Trial

Overview
Publisher Elsevier
Specialty Gastroenterology
Date 2025 Feb 21
PMID 39980577
Authors
Affiliations
Soon will be listed here.
Abstract

Background: Sepsis is the most common acute insult in patients with acute-on-chronic liver failure (ACLF), and circulatory failure portends a poor prognosis in them.

Aim: This study aimed to compare terlipressin and noradrenaline as first-line vasopressors in patients with ACLF and septic shock.

Methods: This prospective, open-label, randomized controlled study was conducted from January 2021 to June 2022 at a tertiary care center. All patients presenting with ACLF as per the chronic liver failure consortium acute on chronic liver failure in cirrhosis study and septic shock were screened. Shock was defined as a mean arterial pressure (MAP) <65 mmHg/systolic blood pressure <90 mmHg. Patients with septic shock nonresponsive to crystalloids/colloids were randomized to receive terlipressin (group I) at 2.6 μg/kg/min and noradrenaline (group II) at 0.1 μg/kg/min. The primary outcome was an MAP >65 mmHg at 6 h. The secondary outcomes were 3-, 7-, 14-, and 28-day mortality, duration of hospital stay, cumulative dose of drug, and new events such as upper gastrointestinal bleed, acute kidney injury, jaundice, and hepatic encephalopathy within 28 days.

Results: A total of 70 patients were randomized to group I (n = 35) and group II (n = 35). According to per-protocol analysis, a higher number of patients achieved an MAP > 65 mmHg at 6 h in group II (n = 23/31, 74%) than in group I (5/34, 14%) ( < 0.001). The 3-and 7-day mortality was significantly higher in group I than in group II, with no difference at 14 and 28 days. The 28-day mortality was highest in ACLF grade-3 in both group II (22/25, 88%) and group I (15/20, 75%).

Conclusion: Terlipressin did not prove to be noninferior to norepinephrine, and therefore, norepinephrine should be the first-line vasopressor in ACLF patients with septic shock. The mortality rate was highest in ACLF grade-3 patients in both the groups, irrespective of the initial response to vasopressors. This indicates that holistic management of these patients is most important.

References
1.
Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J . Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013; 144(7):1426-37, 1437.e1-9. DOI: 10.1053/j.gastro.2013.02.042. View

2.
Biggins S, Angeli P, Garcia-Tsao G, Gines P, Ling S, Nadim M . Diagnosis, Evaluation, and Management of Ascites, Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021; 74(2):1014-1048. DOI: 10.1002/hep.31884. View

3.
Schulz K, Altman D, Moher D . [CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]. Zhong Xi Yi Jie He Xue Bao. 2010; 8(7):604-12. DOI: 10.3736/jcim20100702. View

4.
Wong F, Piano S, Singh V, Bartoletti M, Maiwall R, Alessandria C . Clinical features and evolution of bacterial infection-related acute-on-chronic liver failure. J Hepatol. 2020; 74(2):330-339. DOI: 10.1016/j.jhep.2020.07.046. View

5.
Choudhury A, Kedarisetty C, Vashishtha C, Saini D, Kumar S, Maiwall R . A randomized trial comparing terlipressin and noradrenaline in patients with cirrhosis and septic shock. Liver Int. 2016; 37(4):552-561. DOI: 10.1111/liv.13252. View