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Open Access Research

The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial

Jianfeng Wu1, Lixin Zhou2, Jiyun Liu3, Gang Ma4, Qiuye Kou5, Zhijie He6, Juan Chen1, Bin Ou-Yang1, Minying Chen1, Yinan Li2, Xiaoqin Wu3, Baochun Gu4, Lei Chen5, Zijun Zou6, Xinhua Qiang2, Yuanyuan Chen3, Aihua Lin7, Guanrong Zhang7 and Xiangdong Guan1*

Author Affiliations

1 Department of Critical Care Medicine, The First Affiliated Hospital of Sun Yat-sen University, 58 Zhongshan Er Road, Guangzhou 510080, Guangdong Province, PR China

2 Department of Critical Care Medicine, Foshan First Municipal People's Hospital, 81 Lingnan North Road, Foshan 528000, Guangdong Province, PR China

3 Department of Critical Care Medicine, Guangzhou First Municipal People's Hospital, 1 PanFu Road, Guangzhou 510180, Guangdong Province, PR China

4 Department of Critical Care Medicine, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou 510060, Guangdong Province, PR China

5 Department of Critical Care Medicine, The Sixth Affiliated Hospital of Sun Yat-sen University, 26 Yuancun Erheng Rd, Guangzhou 510655, Guangdong Province, PR China

6 Department of Critical Care Medicine, The Second Affiliated Hospital of Sun Yat-sen University, 107 Yan-Jiang West Road, Guangzhou 510120, Guangdong Province, PR China

7 School of Public Health, Sun Yat-sen University, 74 Zhongshan Er Road, Guangzhou 510080, Guangdong Province, PR China

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Critical Care 2013, 17:R8  doi:10.1186/cc11932

Published: 17 January 2013

Abstract

Introduction

Severe sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Tα1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis.

Methods

We performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis.

Results

A total of 361 patients were allocated to either the control group (n = 180) or Tα1 (n = 181) group. The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02). Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group. No serious drug-related adverse event was recorded.

Conclusions

The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.

Trial registration

ClinicalTrials.gov NCT00711620.