Phase III Study of Angiotensin II Injection Versus Placebo for Treating Refractory Distributive Shock in Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of angiotensin II injection compared to placebo in adult patients with refractory distributive shock. This phase III, randomized, double-blind, placebo-controlled trial aims to improve blood pressure management in patients who continue to have low mean arterial pressure despite treatment with vasoactive drugs. The study involves patients aged 18 to 75 years who have received certain vasoactive medications and meet specific clinical criteria for refractory distributive shock. Participants will be randomly assigned to receive either angiotensin II injection or a placebo through a central vein. The dosage will be adjusted based on mean arterial pressure, with allowable doses ranging from 1.25 to 160 ngkgmin, and treatment duration up to 168 hours. Both groups receive background treatment with catecholamines and other vasopressors as needed. During the study, participants will be monitored for blood pressure response at various time points after drug administration, including 1, 2, and 3 hours. Additional assessments will include organ function scores, mortality at days 7 and 28, changes in vasoactive agent doses, blood lactate levels, heart rate, and recording of adverse events over 28 days. Patients must have central venous and arterial catheters for monitoring and are expected to remain in the study for at least 48 hours of treatment evaluation.

Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock