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NCT04903405 Clinical Trial

Immune Function Monitoring and Immunotherapy in Sepsis

Sepsis Clinical Trial

— IMITS  

Official title:
Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04903405
Other study ID # IMITS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date July 30, 2021

Study information
Verified date May 2021
Source Sun Yat-sen University
Contact Jianfeng Wu
Phone 020-87755766-8453
Email wujianf@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 5000
Est. completion date July 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with sepsis or septic shock according to Sepsis 3.0 Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention is involved in this study

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

References & Publications (3)

Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020. — View Citation

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. — View Citation

Wu JF, Ma J, Chen J, Ou-Yang B, Chen MY, Li LF, Liu YJ, Lin AH, Guan XD. Changes of monocyte human leukocyte antigen-DR expression as a reliable predictor of mortality in severe sepsis. Crit Care. 2011;15(5):R220. doi: 10.1186/cc10457. Epub 2011 Sep 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day mortality 28 days
Secondary Percentage of sepsis patients receiving immune function monitoring 28 days
Secondary Percentage of sepsis patients receiving immunotherapy 28 days
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