INSTINCT
Trial question
What is the role of IgG in ICU patients with necrotizing soft tissue infection?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 100
100 patients (38 female, 62 male).
Inclusion criteria: ICU patients with necrotizing soft tissue infection.
Key exclusion criteria: receipt of > 1 dose of IgG before randomization; necrotizing soft tissue infection for > 48 hours; known hypersensitivity to IgG; known hyperprolinemia.
Interventions
N=50 intravenous polyspecific IgG (infusion at a dose of 25 g once daily for the first 3 days of ICU admission).
N=50 placebo (an equal volume of 0.9% saline once daily for the first 3 days of ICU admission).
Primary outcome
Physical component summary score at 6 m
36 points
31 points
36.0 points
27.0 points
18.0 points
9.0 points
0.0 points
Intravenous polyspecific immunoglobulin
G
Placebo
No significant
difference ↔
No significant difference in physical component summary score at 6 m (36 points vs. 31 points; MD 1, 95% CI -7 to 10).
Secondary outcomes
No significant difference in death at day 180 (22% vs. 28%; RR 0.8, 95% CI 0.4 to 1.59).
No significant difference in patients who received RRT (22% vs. 12%; RR 1.83, 95% CI 0.73 to 4.57).
No significant difference in vasopressor or inotrope use in the ICU (92% vs. 94%; RR 0.98, 95% CI 0.88 to 1.09).
Safety outcomes
No significant differences in serious adverse events, bleeding and amputation at day 180.
Conclusion
In ICU patients with necrotizing soft tissue infection, intravenous polyspecific IgG was not superior to placebo with respect to physical component summary score at 6 m.
Reference
Martin B Madsen, Peter B Hjortrup, Marco B Hansen et al. Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial. Intensive Care Med. 2017 Nov;43(11):1585-1593.
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