6/28/23, 12:05 AM CENSER Pathway Feedback Search Clinical Topics Home Studies CENSER CENSER Disease Sepsis and septic shock Trial question What is the role of early use of norepinephrine in patients with septic shock? Study design Single center Double blinded RCT Population Characteristics of study participants 52.0% female N = 310 48.0% male 310 patients (162 female, 148 male) Inclusion criteria: adult patients diagnosed with sepsis with hypotension Key exclusion criteria: septic shock diagnostic criteria for > 1 hour before randomization, acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, active gastrointestinal hemorrhage Interventions N=155 early norepinephrine (infusion of a dose of 0.05 g/kg/min of body weight plus fluid resuscitation) N=155 placebo (5% dextrose in water plus standard treatment) Primary outcome Shock control rate by 6 hours after initiation of resuscitation 76.1 % 76.1 https://web.pathway.md/studies/recseFcqChB57SsKX 1/2 6/28/23, 12:05 AM CENSER Pathway 57.1 % 48.4 38.0 % Significant increase 19.0 % NNH = 4 0.0 % Early norepinephrine Placebo Significant increase in shock control rate by 6 hours after initiation of resuscitation (76.1% vs. 48.4%; OR 3.4, 95% CI 2.09 to 5.53) Secondary outcomes No significant difference in the rate of death by day 28 (15.5% vs. 21.9%; RR 0.79, 95% CI 0.53 to 1.11) No significant difference in hospital death (22.6% vs. 24.5%; RR 0.95, 95% CI 0.72 to 1.24) Significant increase in achievement of target mean arterial BP by 6 hours (86.5% vs. 67.1%; RR 3.13, 95% CI 1.77 to 5.53) Safety outcomes No significant differences in limb ischemia, intestinal ischemia, ARDS, hospital-acquired infection, upper gastrointestinal hemorrhage, skin necrosis. Significant differences in cardiogenic pulmonary edema (14.4% vs. 27.7%), new-onset arrhythmia (11% vs. 20%). Conclusion In adult patients diagnosed with sepsis with hypotension, early norepinephrine was superior to placebo with respect to shock control rate by 6 hours after initiation of resuscitation. Reference Chairat Permpikul, Surat Tongyoo, Tanuwong Viarasilpa et al. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1097-1105. Open reference URL https://web.pathway.md/studies/recseFcqChB57SsKX 2/2