Sepsis SyndromeNCT03842371
Metabolism of Branched-chain Amino Acids in Monocyte/Macrophage During Sepsis
An observational study of Sepsis Syndrome, run by West China Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis Syndrome
- What is being tested?
- Metabolic level of BCAAs in monocytes and macrophages
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 11 Feb 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are diagnosed as sepsis, with or without type 2 diabetes.
Who may be able to join
- patients diagnosed with sepsis, with or without type 2 diabetes
- healthy volunteers
Who cannot join
- 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
About this study
Official title: Metabolism of Branched-chain Amino Acids in Monocyte and Macrophage During Sepsis
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.
Read the detailed 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.
- Conditions
- Sepsis Syndrome
- Being tested
- Metabolic level of BCAAs in monocytes and macrophages
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic level of BCAAs in monocytes and macrophagesOther
Metabolic level of BCAAs in monocytes and macrophages
| Study group | Role | What they receive |
|---|---|---|
| Sepsis with type 2 diabetes | Sepsis patients with type 2 diabetes Receives: Other: Metabolic level of BCAAs in monocytes and macrophages | |
| Sepsis without type 2 diabetes | Sepsis patients without type 2 diabetes Receives: Other: Metabolic level of BCAAs in monocytes and macrophages | |
| Volunteers | Healthy volunteers Receives: Other: Metabolic level of BCAAs in monocytes and macrophages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular levels of branched-chain amino acids in monocytes
BCAAs Assay Kit will be used to measure the intracellular levels of BCAAs in monocytes.
Measured: up to 14 day after diagnose of sepsis
Secondary outcomes (10)
Plasma levels of branched-chain amino acids
BCAAs Assay Kit will be used to measure the plasma levels of BCAAs.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis
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.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain α-ketoacid dehydrogenase in monocytes
The expression of branched-chain α-ketoacid dehydrogenase in monocytes will be determined by qPCR and western blot.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of PP2Cm in monocytes
The expression of mitochondrial-targeted phosphatase, PP2Cm in monocytes will be determined by qPCR and western blot.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis
The plasma level of IL-1β
The plasma level of IL-1β will be determined by ELISA kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of TNF-α
The plasma level of TNF-α will be determined by ELISA kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of IL-10
The level of IL-10 will be determined by ELISA kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1α.
The plasma level of chemokine MIP-1α will be determined by ELISA kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1β.
The plasma level of chemokine MIP-1β will be determined by ELISA kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
The phagocytic index of monocytes.
The phagocytic index of monocytes will be determined by a E.coli Phagocytosis Assay Kit.
Measured: 1,3,5,7,10,14 day after diagnose of sepsis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start11 Feb 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842371
- Sponsor's protocol ID
- 2018-081
- Status last verified
- Feb 2019
- First submitted
- 8 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism of Branched-chain Amino Acids in Monocyte and Macrophage During Sepsis
- ClinicalTrials.gov ID
- NCT03842371
- Acronym / sponsor ID
- 2018-081
- Conditions
- Sepsis Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 11 Feb 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis with type 2 diabetes | – | Other: Metabolic level of BCAAs in monocytes and macrophagesSepsis patients with type 2 diabetes |
| Sepsis without type 2 diabetes | – | Other: Metabolic level of BCAAs in monocytes and macrophagesSepsis patients without type 2 diabetes |
| Volunteers | – | Other: Metabolic level of BCAAs in monocytes and macrophagesHealthy volunteers |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed as sepsis, with or without type 2 diabetes.
Key inclusion criteria (2 listed)
- patients diagnosed with sepsis, with or without type 2 diabetes
- healthy volunteers
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic level of BCAAs in monocytes and macrophagesMetabolic level of BCAAs in monocytes and macrophages | Other | Sepsis with type 2 diabetes, Sepsis without type 2 diabetes, Volunteers |
Primary outcome
Intracellular levels of branched-chain amino acids in monocytes
Time frame: up to 14 day after diagnose of sepsis
BCAAs Assay Kit will be used to measure the intracellular levels of BCAAs in monocytes.
10 secondary outcomes
Plasma levels of branched-chain amino acids
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain amino acid aminotransferase in monocytes
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of branched-chain α-ketoacid dehydrogenase in monocytes
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis
The expression of PP2Cm in monocytes
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis
The plasma level of IL-1β
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of TNF-α
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of IL-10
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1α.
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The plasma level of chemokine MIP-1β.
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
The phagocytic index of monocytes.
Time frame: 1,3,5,7,10,14 day after diagnose of sepsis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Syndrome, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracellular levels of branched-chain amino acids in monocytes (time frame: up to 14 day after diagnose of sepsis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.