Effectiveness of anisodamine for the treatment of critically ill patients with septic shock (ACIdoSIS study): study protocol for randomized controlled trial

Zhongheng Zhang; Jiancang Zhou; You Shang; Xin'an Wang; Rui Yin; Zhenhua Zhu; Wensen Chen; Xin Tian; Yuetian Yu; Xiangrong Zuo; Kun Chen; Xuqing Ji; Hongying Ni; Anisodamine Critically Ill SeptIc Shock (ACIdoSIS) study group

doi:10.3978/j.issn.2305-5839.2015.10.03

Effectiveness of anisodamine for the treatment of critically ill patients with septic shock (ACIdoSIS study): study protocol for randomized controlled trial

Ann Transl Med. 2015 Oct;3(17):246. doi: 10.3978/j.issn.2305-5839.2015.10.03.

Affiliation

¹ 1 Department of Critical Care Medicine, Jinhua Municipal Central Hospital, Jinhua Hospital of Zhejiang University, Jinhua 321000, China ; 2 Department of Critical Care Medicine, Sir Run Run Shaw hospital, Zhejiang University School of Medicine, Hangzhou 310058, China ; 3 Department of Critical Care Medicine, Union Hospital, Tongji Medical Collegue, Huazhong University of Science and Technology, Wuhan 430022, China ; 4 Department of Critical Care Medicine, Binzhou People's Hospital of Shandong Province, Binzhou 256600, China ; 5 Department of Critical Care Medicine, Peace Hospital of Changzhi Medical College, the First Clinical College, Changzhi 046011, China ; 6 Department of Infection Control and Hospital Epidemiology, the First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China ; 7 Department of Critical Care Medicine, Lishui Municipal Central Hospital, Lishui 323000, China ; 8 Department of Critical Care Medicine, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200001, China ; 9 Department of Critical Care Medicine, the First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China.

PMID: 26605292
PMCID: PMC4620101
DOI: 10.3978/j.issn.2305-5839.2015.10.03

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/).

Keywords: Anisodamine; intensive care unit (ICU); mortality; randomized controlled trial; septic shock.

Associated data

ClinicalTrials.gov/NCT02442440