The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS
October 1, 2023 updated by: Jingyuan,Xu, Southeast University, China
To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.
Study Overview
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 Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jingyuan Xu, M.D.
- Phone Number: 008613851417209
- Email: 13851417209@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study enrolled sepsis patients
Description
Inclusion Criteria:
Diagnosed as Sepsis 3.0 Patients signing informed consent
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Survivors
Sepsis induced ARDS patients who survived
|
Taking peripheral blood of no more than 3ml
|
|
Nonsurvivors
Sepsis induced ARDS patients who not survived
|
Taking peripheral blood of no more than 3ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 28 day
|
28day mortality
|
28 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jingyuan Xu, M.D., Southeast university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
August 31, 2023
First Submitted That Met QC Criteria
September 29, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 1, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022ZDSYLL402-P01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.