SepsisNCT06258252
Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis
An observational study of Sepsis, run by West China Hospital.
Trial summary
The current project was designed to examine the effects of BCAA metabolic dysfunction on cardiac function in septic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Effect of BCAAs metabolic dysfunction on cardiac function in sepsis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 15 Mar 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis
Who may be able to join
- patients diagnosed with sepsis with or without type 2 diabetes
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 informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis: an Observational Study
The current project was designed to examine the effects of BCAA metabolic dysfunction on cardiac function in septic patients.
Read the detailed description
Patients with sepsis and with/without type 2 diabetes will be included. Patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. Peripheral blood plasma and PBMCs were separated by differential centrifugation: the concentration of BCAAs in serum and PBMCs; the expression of PBMCs BCAAs metabolic enzymes BCAT 1, BCKDH, and PP 2 Cm by WB; and the levels of AST, ALT, LDH, CK, and CK-MB
- Conditions
- Sepsis
- Being tested
- Effect of BCAAs metabolic dysfunction on cardiac function in sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of BCAAs metabolic dysfunction on cardiac function in sepsisOther
Effect of BCAAs metabolic dysfunction on cardiac function in sepsis
| Study group | Role | What they receive |
|---|---|---|
| Patients who are diagnosed as sepsis, with type 2 diabetes. | 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Receives: Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis | |
| Patients who are diagnosed as sepsis, without type 2 diabetes. | 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Receives: Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Sepsis induced cardiomyopathy
Diagnostic criteria for Sepsis induced cardiomyopathy, TroponinT > 0.01 ng/ml
Measured: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Secondary outcomes (4)
Plasma levels of TroponinT
If multiple measurements is available during the first 7 days, the mean measurement will be used for analysis.
Measured: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Plasma levels of type B natriuretic peptide
If multiple measurements is available during the first 7 days, the mean measurement will be used for analysis.
Measured: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
ejection fraction
If multiple measurements is available during the first 7 day, the mean measurement will be used for analysis.
Measured: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Left ventricular and right ventricular size
If multiple measurements is available during the first 7 day, the mean measurement will be used for analysis.
Measured: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- Investigators
- Fengmin Luo, PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258252
- Sponsor's protocol ID
- 20240201
- Status last verified
- Jun 2024
- First submitted
- 5 Feb 2024
- Last updated
- 14 Jun 2024
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis: an Observational Study
- ClinicalTrials.gov ID
- NCT06258252
- Acronym / sponsor ID
- 20240201
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 14 Feb 2024 (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 effects of BCAA metabolic dysfunction on cardiac function in septic patients.
Detailed description
Patients with sepsis and with/without type 2 diabetes will be included. Patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. Peripheral blood plasma and PBMCs were separated by differential centrifugation: the concentration of BCAAs in serum and PBMCs; the expression of PBMCs BCAAs metabolic enzymes BCAT 1, BCKDH, and PP 2 Cm by WB; and the levels of AST, ALT, LDH, CK, and CK-MB
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who are diagnosed as sepsis, with type 2 diabetes. | – | Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. |
| Patients who are diagnosed as sepsis, without type 2 diabetes. | – | Other: Effect of BCAAs metabolic dysfunction on cardiac function in sepsis1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis
Key inclusion criteria (1 listed)
- patients diagnosed with sepsis with or without type 2 diabetes
Key exclusion criteria (1 listed)
- patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age younger than 18 years patients who cannot provide 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 |
|---|---|---|
| Effect of BCAAs metabolic dysfunction on cardiac function in sepsisEffect of BCAAs metabolic dysfunction on cardiac function in sepsis | Other | Patients who are diagnosed as sepsis, with type 2 diabetes., Patients who are diagnosed as sepsis, without type 2 diabetes. |
Primary outcome
The incidence of Sepsis induced cardiomyopathy
Time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Diagnostic criteria for Sepsis induced cardiomyopathy, TroponinT > 0.01 ng/ml
4 secondary outcomes
Plasma levels of TroponinT
Time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Plasma levels of type B natriuretic peptide
Time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
ejection fraction
Time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Left ventricular and right ventricular size
Time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Fengmin Luo, PhD principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, 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 1 inclusion and 1 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 14 Jun 2024. 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?
Contact Chunling Jiang, PhD (18980601096, jiangchunling@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Sepsis induced cardiomyopathy (time frame: up to 7 days post-ICU admission, or at hospital discharge, whichever comes first). 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 14 Jun 2024.