Catecholamines in pediatric cold shock
Trial question
Is a combination of norepinephrine and dobutamine superior to epinephrine in children with fluid-refractory cold septic shock?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 67
67 patients (29 female, 38 male).
Inclusion criteria: pediatric patients 2 months to < 18 years old with fluid refractory cold septic shock.
Key exclusion criteria: fulminant myocarditis; congenital heart disease; severe acute malnutrition; CKD; receipt of vasoactive agents.
Interventions
N=34 norepinephrine plus dobutamine (dose titration of 0.1-0.3 and 10-20 mcg/kg/min, respectively).
N=33 epinephrine (dose titration of 0.1-0.3 mcg/kg/min).
Primary outcome
Shock resolution at 1 hour of therapy
17.6%
9%
17.6 %
13.2 %
8.8 %
4.4 %
0.0 %
Norepinephrine plus
dobutamine
Epinephrine
No significant
difference ↔
No significant difference in shock resolution at 1 hour of therapy (17.6% vs. 9%; RR 2, 95% CI 0.54 to 7.35).
Secondary outcomes
No significant difference in shock resolution at 6 hours of therapy (76.4% vs. 54.5%; RR 1.69, 95% CI 0.92 to 3.13).
Significantly shorter time to achieving shock resolution (3 hours vs. 6 hours; HR 0.54, 95% CI 0.32 to 0.9).
No significant difference in death at day 28 (23.5% vs. 39.3%; RR 0.59, 95% CI 0.28 to 1.25).
Safety outcomes
No significant difference in adverse events.
Conclusion
In pediatric patients 2 months to < 18 years old with fluid refractory cold septic shock, norepinephrine plus dobutamine was not superior to epinephrine with respect to shock resolution at 1 hour of therapy.
Reference
Kiran Kumar Banothu, Jhuma Sankar, U Vijaya Kumar et al. A Randomized Controlled Trial of Norepinephrine Plus Dobutamine Versus Epinephrine As First-Line Vasoactive Agents in Children With Fluid Refractory Cold Septic Shock. Crit Care Explor. 2022 Dec 28;5(1):e0815. eCollection 2023 Jan.
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