Adjunctive terlipressin versus placebo in the treatment of refractory septic shock: a randomized, placebo-controlled trial
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Issued Date
2025-12-01
Resource Type
ISSN
13648535
eISSN
1466609X
Scopus ID
2-s2.0-105019506039
Journal Title
Critical Care
Volume
29
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Critical Care Vol.29 No.1 (2025)
Suggested Citation
Tongyoo S., Chayakul C., Aritajati T., Tanyalakmara T. Adjunctive terlipressin versus placebo in the treatment of refractory septic shock: a randomized, placebo-controlled trial. Critical Care Vol.29 No.1 (2025). doi:10.1186/s13054-025-05669-0 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/112814
Title
Adjunctive terlipressin versus placebo in the treatment of refractory septic shock: a randomized, placebo-controlled trial
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Abstract
Background: Terlipressin’s role as an adjunctive vasopressor in septic shock remains controversial. We aimed to evaluate the efficacy of terlipressin versus placebo as an additional vasopressor in refractory septic shock. Methods: We conducted a single-center, prospective, double-blind, randomized controlled trial in a medical intensive care unit. Adult patients with septic shock requiring norepinephrine > 0.2 mcg/kg/min or epinephrine were randomly assigned (1:1) to receive terlipressin or placebo. The primary outcome was the proportion of patients achieving mean arterial pressure ≥ 65 mmHg with total catecholamine equivalent dose below 0.2 mcg/kg/min at 6 h after randomization. Results: A total of 130 patients were enrolled: 66 in the terlipressin group and 64 in the placebo group. Baseline characteristics were comparable. The median (interquartile range) baseline norepinephrine equivalent dose was 0.39 (0.29 − 0.73) mcg/kg/min for terlipressin versus 0.39 (0.27 − 0.62) mcg/kg/min for placebo. Pneumonia (57.6% vs 48.4%) and intra-abdominal infection (21.2% vs 23.4%) were the most common etiologies in the terlipressin and placebo arms, respectively. Significantly more patients met the primary outcome with terlipressin than with placebo (22.7% vs 9.4%; relative risk [RR] = 1.53, 95% confidence interval [CI] = 1.09–2.14; P = 0.039). The 28-day mortality was 60.6% in the terlipressin group versus 64.1% in the placebo group (RR = 0.93, 95% CI = 0.66–1.31; P = 0.68). Digital ischemia occurred in 28.8% versus 27.4% (P = 0.86). Conclusions: Among patients with refractory septic shock, adjunctive terlipressin reduced the proportion of patients requiring high-dose catecholamines at 6 h, without significantly altering mortality or digital ischemia risk. Trial registration: Clinicaltrials.gov (NCT 04339868). The registration date was April 7, 2020.