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The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymosin alpha 1+Standard Therapy | Experimental | Patients receive treatment based on SSC guideline with additional thymosin alpha1 |
|
| normal saline+standard therapy | Placebo Comparator | Patients receive treatment based on SSC guideline with additional normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymosin alpha 1 | Drug | 1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day Mortality | The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| SOFA score | SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups. | 7 days |
| Immune response to Thymosin alpha 1 | HLA-DR expression on CD14+,ratio between CD4+ and CD8+, CRP on day 0, 3, 7 after the start of the infusion in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guan Xiangdong, M.D | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23327199 | Derived | Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| 7 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |