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Recruiting Phase 3 NCT06351150

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

Trial Parameters

Condition Vasodilatory Shock
Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 214
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-23
Completion 2027-06
Interventions
Angiotensin II Injection0.9% sodium chloride injection

Brief Summary

A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group.

Eligibility Criteria

Inclusion Criteria: * age: 18 years to 75 years old, male or female; * diagnosis of distributive shock; * on the basis of the treatment of total vasoactive drugs dose \> 0.2 μg/kg/min norepinephrine (or equivalent dose of another vasoactive drug: such as epinephrine \> 0.2 μg/kg/min, dopamine \> 30 μg/kg/min, phenylephrine \> 2 μg/kg/min, vasopressin \> 0.08 U/min) and continuous treatment for at least 6 hours and no more than 48 hours, the patient's mean arterial pressure can still only be maintained between 55 and 70 mmHg, or do not reach the target MAP assessed by clinicians, it can be diagnosed as refractory distributive shock. * have central venous access and arterial catheters, and are expected to be present for at least the first 48 hours of the study. * indwelling catheter, and expected to be present for at least the first 48 hours of the study. * patient has received at least 30 mL/kg of crystalloid or colloid volume in the previous 24 hours or has undergone adequate volume re

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