6/28/23, 11:36 PM INSTINCT Pathway Feedback Search Clinical Topics Home Studies INSTINCT INSTINCT Disease Disease Fournier's gangrene Necrotizing fasciitis 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 N = 100 62.0% male 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 36.0 36 31 27.0 https://web.pathway.md/studies/recnzC1nSpXg3x0i7 1/2 6/28/23, 11:36 PM INSTINCT Pathway 18.0 9.0 No significant difference 0.0 Intravenous polyspecific immunoglobulin G Placebo No significant difference in physical component summary score at 6 m (36 vs. 31; 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 the percentage of 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. Open reference URL https://web.pathway.md/studies/recnzC1nSpXg3x0i7 2/2