The Effect of rTEM in the Prognosis and Severity of Sepsi... | NCT06063707

Studies
The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS

NCT06063707

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Oct 3, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Taking peripheral blood

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Estimated

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Sep 29, 2023

First Posted Date

Oct 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2023

Last Update Posted Date

Oct 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jingyuan,Xu, Principal Investigator, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survivors		Sepsis induced ARDS patients who survived	Other: Taking peripheral blood
Nonsurvivors		Sepsis induced ARDS patients who not survived	Other: Taking peripheral blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Taking peripheral blood	Other	Taking peripheral blood of no more than 3ml	Nonsurvivors Survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	28day mortality	28 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study enrolled sepsis patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jingyuan Xu, M.D.	Contact	008613851417209		13851417209@163.com

Overall Officials

Name	Affiliation	Role
Jingyuan Xu, M.D.	Southeast University	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided