A phase III randomised, double-blind, placebo-controlled, multicentre efficacy and safety clinical trial of angiotensin II in paediatric patients of 0 to 17 years of age with refractory hypotension in distributive shock receiving fluid resuscitation and standard-of-care vasopressors

refractory hypotension in distributive shock

Change in the dose of SOC vasopressors, expressed as norepinephrine base equivalent dose (NED) sum/hour, from baseline to the first 6 hours of IMP

Change in MAP as mean/h from baseline to the first 3 hours, 3–6, 6–12, 12–24, 24–48 hours, Change in the dose of SOC vasopressors, expressed as norepinephrine base equivalent dose (NED) sum/hour, from baseline to the first 3 hours, 3–6, 6–12, 12–24, 24–48 hours, Time from start of IMP administration to first maintenance dose sustained at the same dose for ≥ 1 hour, and the dose at that time, Change in paediatric logistic organ dysfunction (PELOD-2) score from baseline (all participants are at the PICU at baseline) to 48 hours (for participants who remain at the PICU at this time) and to day 7 (for participants who remain at the PICU at this time), Change in blood lactate from baseline to 6, 12, 24 and 48 hours, Proportion of participants who achieve a ≥ 25%, ≥ 50% and ≥ 75% reduction in the dose of SOC vasopressors, expressed as NED sum/hour, from baseline to 6 hours, and who are alive, blinded to their treatment assignment, and have not been withdrawn at 6 hours

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