Terlipressin vs. Norepinephrine in Septic Shock
Trial question
What is the role of terlipressin in patients with septic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 526
526 patients (195 female, 331 male).
Inclusion criteria: patients in the ICU with septic shock.
Key exclusion criteria: unstable coronary syndrome, previous use of terlipressin for arterial BP support before entry, malignancy or other irreversible disease with poor prognosis, acute mesenteric ischemia.
Interventions
N=260 terlipressin (20-160 mcg/hr with maximum infusion rate of 4 mg/day before open-label vasopressors).
N=266 norepinephrine (4-30 mcg/min before open-label vasopressors).
Primary outcome
Death at day 28
40%
38%
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Terlipressin
Norepinephrine
No significant
difference ↔
No significant difference in death at day 28 (40% vs. 38%; RR 1.053, 95% CI 0.74 to 1.5).
Secondary outcomes
No significant difference in change in SOFA score on day 7 (-7 points vs. -6 points; AD -1 points, 95% CI -2.27 to 0.27).
No significant difference in days alive and free of vasopressor (15.5 days vs. 14.66 days; AD 0.84 days, 95% CI -1.19 to 2.87).
Safety outcomes
No significant differences in acute MI or ischemia, life-threatening arrhythmia, hyponatremia, acute mesenteric ischemia.
Significant differences in serious adverse events (30% vs. 12%), digital ischemia (12.6% vs. 0.35%), diarrhea (2.72% vs. 0.35%).
Conclusion
In patients in the ICU with septic shock, terlipressin was not superior to norepinephrine with respect to death at day 28.
Reference
Zi-Meng Liu, Juan Chen, Qiuye Kou et al. Terlipressin versus norepinephrine as infusion in patients with septic shock: a multicentre, randomised, double-blinded trial. Intensive Care Med. 2018 Nov;44(11):1816-1825.
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