NCT03842371

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

February 8, 2019

Last Update Submit

February 14, 2019

Conditions

Sepsis Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Plasma levels of branched-chain amino acids

    1,3,5,7,10,14 day after diagnose of sepsis

  • The expression of branched-chain amino acid aminotransferase in monocytes

    1,3,5,7,10,14 day after diagnose of sepsis

  • The expression of branched-chain α-ketoacid dehydrogenase in monocytes

    1,3,5,7,10,14 day after diagnose of sepsis

  • The expression of PP2Cm in monocytes

    1,3,5,7,10,14 day after diagnose of sepsis

  • The plasma level of IL-1β

    1,3,5,7,10,14 day after diagnose of sepsis.

  • +5 more secondary outcomes

Study Arms (3)

Sepsis with type 2 diabetes

Sepsis patients with type 2 diabetes

Other: Metabolic level of BCAAs in monocytes and macrophages

Sepsis without type 2 diabetes

Sepsis patients without type 2 diabetes

Other: Metabolic level of BCAAs in monocytes and macrophages

Volunteers

Healthy volunteers

Other: Metabolic level of BCAAs in monocytes and macrophages

Interventions

Metabolic level of BCAAs in monocytes and macrophagesOTHER

Metabolic level of BCAAs in monocytes and macrophages

Sepsis with type 2 diabetesSepsis without type 2 diabetesVolunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are diagnosed as sepsis, with or without type 2 diabetes.

You may qualify if:

  • patients diagnosed with sepsis, with or without type 2 diabetes
  • healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 15, 2019

Study Start

February 11, 2019

Primary Completion

December 30, 2021

Study Completion

February 28, 2022

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share