SepsisNCT06063707
The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS
An observational study of Sepsis, run by Southeast University, China.
Trial summary
To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Taking peripheral blood
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study enrolled sepsis patients
Who may be able to join
- Diagnosed as Sepsis 3.0 Patients signing informed consent
Who cannot join
- Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome
Trial locations and contacts
No sites are listed yet.
About this study
To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.
Read the detailed description
90 patients will be included in this study. Blood samples from these patients in the first day, the third day, were maintained and tested to detect the change of rTEM level. Severity of illness and survival status of every patient were recorded within 28 days. The objective is to observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.
- Conditions
- Sepsis
- Being tested
- Taking peripheral blood
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking peripheral bloodOther
Taking peripheral blood of no more than 3ml
| Study group | Role | What they receive |
|---|---|---|
| Survivors | Sepsis induced ARDS patients who survived Receives: Other: Taking peripheral blood | |
| Nonsurvivors | Sepsis induced ARDS patients who not survived Receives: Other: Taking peripheral blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
28day mortality
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063707
- Sponsor's protocol ID
- 2022ZDSYLL402-P01
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS
- ClinicalTrials.gov ID
- NCT06063707
- Acronym / sponsor ID
- 2022ZDSYLL402-P01
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 2 Oct 2023 (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.
To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.
Detailed description
90 patients will be included in this study. Blood samples from these patients in the first day, the third day, were maintained and tested to detect the change of rTEM level. Severity of illness and survival status of every patient were recorded within 28 days. The objective is to observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survivors | – | Other: Taking peripheral bloodSepsis induced ARDS patients who survived |
| Nonsurvivors | – | Other: Taking peripheral bloodSepsis induced ARDS patients who not survived |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study enrolled sepsis patients
Key inclusion criteria (1 listed)
- Diagnosed as Sepsis 3.0 Patients signing informed consent
Key exclusion criteria (1 listed)
- Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome
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 |
|---|---|---|
| Taking peripheral bloodTaking peripheral blood of no more than 3ml | Other | Nonsurvivors, Survivors |
Primary outcome
Mortality
Time frame: 28 day
28day mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Jingyuan Xu, M.D. principal investigator
Southeast University
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Southeast University, China.
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 3 Oct 2023. 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 Jingyuan Xu, M.D. (008613851417209, 13851417209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 day). 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 3 Oct 2023.