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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03842371
Other study ID # 2018-081
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 11, 2019
Est. completion date February 28, 2022

Study information

Verified date February 2019
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The current project was designed to examine the metabolic level of branched-chain amino acids in plasm and monocyte/macrophage, and its role in immune dysfunction during sepsis.


Description:

In this study, the investigators will collect the peripheral blood of 1,3,7,14 day after diagnose of sepsis. Then, the concentration of branched-chain amino acids(BCAAs) in monocytes and plasma, and the expression of BCAAs metabolic enzymes in monocytes will be determined. Additionally, the inflammatory cytokines, e.g., Interleukin-1β (IL-1β), Tumor necrosis factor-α (TNF-α), Interleukin-10 (IL-10), the chemokines macrophage inflammatory proteins 1α and 1β (MIP-1α and 1β) in the peripheral blood and the phagocytic function of monocytes will also be detected. The current project was designed to examine the metabolic level of branched-chain amino acids in plasm and monocyte/macrophage, and its role in immune dysfunction during sepsis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date February 28, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients diagnosed with sepsis, with or without type 2 diabetes

- healthy volunteers

Exclusion Criteria:

- patients with immunodeficient diseases

- patients who accept glucocorticoid or immunosuppressant

- patients with an age younger than 18 years

- patients who cannot provide the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Metabolic level of BCAAs in monocytes and macrophages
Metabolic level of BCAAs in monocytes and macrophages

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Intracellular levels of branched-chain amino acids in monocytes BCAAs Assay Kit will be used to measure the intracellular levels of BCAAs in monocytes. up to 14 day after diagnose of sepsis
Secondary Plasma levels of branched-chain amino acids BCAAs Assay Kit will be used to measure the plasma levels of BCAAs. 1,3,5,7,10,14 day after diagnose of sepsis
Secondary The expression of branched-chain amino acid aminotransferase in monocytes The expression of branched-chain amino acid aminotransferase in monocytes will be determined by qPCR and western blot. 1,3,5,7,10,14 day after diagnose of sepsis
Secondary The expression of branched-chain a-ketoacid dehydrogenase in monocytes The expression of branched-chain a-ketoacid dehydrogenase in monocytes will be determined by qPCR and western blot. 1,3,5,7,10,14 day after diagnose of sepsis
Secondary The expression of PP2Cm in monocytes The expression of mitochondrial-targeted phosphatase, PP2Cm in monocytes will be determined by qPCR and western blot. 1,3,5,7,10,14 day after diagnose of sepsis
Secondary The plasma level of IL-1ß The plasma level of IL-1ß will be determined by ELISA kit. 1,3,5,7,10,14 day after diagnose of sepsis.
Secondary The plasma level of TNF-a The plasma level of TNF-a will be determined by ELISA kit. 1,3,5,7,10,14 day after diagnose of sepsis.
Secondary The plasma level of IL-10 The level of IL-10 will be determined by ELISA kit. 1,3,5,7,10,14 day after diagnose of sepsis.
Secondary The plasma level of chemokine MIP-1a. The plasma level of chemokine MIP-1a will be determined by ELISA kit. 1,3,5,7,10,14 day after diagnose of sepsis.
Secondary The plasma level of chemokine MIP-1ß. The plasma level of chemokine MIP-1ß will be determined by ELISA kit. 1,3,5,7,10,14 day after diagnose of sepsis.
Secondary The phagocytic index of monocytes. The phagocytic index of monocytes will be determined by a E.coli Phagocytosis Assay Kit. 1,3,5,7,10,14 day after diagnose of sepsis.
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