IMITS: Immune Function Monitoring and Immunotherapy in Sepsis
Sponsor
Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04903405
Collaborator
(none)
5,000
1.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
5000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China
Anticipated Study Start Date
:
Jun 1, 2021
Anticipated Primary Completion Date
:
Jun 30, 2021
Anticipated Study Completion Date
:
Jul 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sepsis
|
Other: No intervention
No intervention is involved in this study
|
Outcome Measures
Primary Outcome Measures
- 28-day mortality [28 days]
Secondary Outcome Measures
- Percentage of sepsis patients receiving immune function monitoring [28 days]
- Percentage of sepsis patients receiving immunotherapy [28 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with sepsis or septic shock according to Sepsis 3.0
Exclusion Criteria:
- None
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
Responsible Party:
Wu Jianfeng,
chief physician,
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04903405
Other Study ID Numbers:
- IMITS
First Posted:
May 26, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021