Terlipressin vs. Norepinephrine in Cirrhosis with Septic Shock
Trial question
Is terlipressin noninferior to norepinephrine in patients with cirrhosis and septic shock?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
18.0% female
82.0% male
N = 84
84 patients (15 female, 69 male).
Inclusion criteria: patients admitted to the ICU with decompensated liver cirrhosis and septic shock.
Key exclusion criteria: valvular heart disease; coronary artery disease; acute mesenteric ischemia; PAD; CKD; uncontrolled or refractory variceal hemorrhage.
Interventions
N=42 terlipressin (titration and infusion at a rate of 1.3 to 5.2 mcg/min over 24 hours).
N=42 norepinephrine (titration and infusion at a rate of 7.5 mcg/min and gradual increase to a maximum dose of 60 mcg/min).
Primary outcome
Percentage of patients achieving mean arterial pressure > 65 mmHg at 48 hours
92.9%
69.1%
92.9 %
69.7 %
46.5 %
23.2 %
0.0 %
Terlipressin
Norepinephrine
Significant
increase ▲
NNT = 4
Significant increase in the percentage of patients achieving mean arterial pressure > 65 mmHg at 48 hours (92.9% vs. 69.1%; AD 23.8%, 95% CI 7.2 to 40.4).
Secondary outcomes
Significant decrease in new-onset variceal hemorrhage (0% vs. 9.5%).
Significant increase in shock reversal at 48 hours (33.3% vs. 11.9%; AD 21.4%, 95% CI 3.35 to 39.45).
Significant increase in survival at 48 hours (95.2% vs. 71.4%; AD 23.8%, 95% CI 8.11 to 39.49).
Safety outcomes
No significant difference in adverse events.
Significant difference in time to adverse events (6 hours vs. 21 hours).
Conclusion
In patients admitted to the ICU with decompensated liver cirrhosis and septic shock, terlipressin was superior to norepinephrine with respect to the percentage of patients achieving mean arterial pressure > 65 mmHg at 48 hours.
Reference
Ashok Choudhury, Chandan K Kedarisetty, Chitranshu Vashishtha et al. A randomized trial comparing terlipressin and noradrenaline in patients with cirrhosis and septic shock. Liver Int. 2017 Apr;37(4):552-561.
Open reference URL