@article{ATM7992,
author = {Zhongheng Zhang and Jiancang Zhou and You Shang and Xin’an Wang and Rui Yin and Zhenhua Zhu and Wensen Chen and Xin Tian and Yuetian Yu and Xiangrong Zuo and Kun Chen and Xuqing Ji and Hongying Ni and for the Anisodamine Critically Ill SeptIc Shock (ACIdoSIS) study group},
title = {Effectiveness of anisodamine for the treatment of critically ill patients with septic shock (ACIdoSIS study): study protocol for randomized controlled trial},
journal = {Annals of Translational Medicine},
volume = {3},
number = {17},
year = {2015},
keywords = {},
abstract = {Background: Septic shock is an important contributor of mortality in the intensive care unit (ICU). Although strenuous effort has been made to improve its outcome, the mortality rate is only marginally decreased. The present study aimed to investigate the effectiveness of anisodamine in the treatment of septic shock, in the hope that the drug will provide alternatives to the treatment of septic shock.
Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically ill patients with septic shock requiring vasopressor use. Blocked randomization was performed where anisodamine and control treatments were allocated at random in a ratio of 1:1 in blocks of sizes 2, 4, 6, 8, and 10 to 354 subjects. Interim analysis will be performed. The primary study end point is the hospital mortality, and other secondary study endpoints include ICU mortality, length of stay in ICU and hospital, organ failure free days. Adverse events including new onset psychosis, urinary retention, significant hypotension and tachycardia will be reported.
Discussion: The study will provide new insight into the treatment of septic shock and can help to reduce mortality rate of septic shock.
Trial registration: NCT02442440 (https://register.clinicaltrials.gov/).},
issn = {2305-5847}, url = {https://atm.amegroups.org/article/view/7992}
}