A Prospective Observational Study of Sepsis | NCT05309889

Studies
A Prospective Observational Study of Sepsis

NCT05309889

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Unknown status

Last Update Posted

May 31, 2022Actual

Enrollment

174Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

no intervention

Countries

China

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 12, 2022Actual

Primary Completion Date

May 2023Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Mar 30, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 4, 2022Actual

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

May 25, 2022

Last Update Posted Date

May 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection and is associated with high morbidity and mortality. Sepsis3 gives sepsis a broad definition, reflecting the heterogeneity of the disease. So we need a precise treatment with a stratification of patient prognosis in order to reduce mortality in patients with sepsis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

174Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high exposure level		Patients have a high level of exposure factors	Other: no intervention
low exposure level		Patients have a low level of exposure factors	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	high exposure level low exposure level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality rate	all-cause deaths that occurred in 28 days	28 days after diagnosis of sepsis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who met the Sepsis3 diagnostic criteria.

Exclusion Criteria:

Absence of laboratory test items (blood routine examination, coagulation function, liver function, biochemistry, urine routine examination, urine renal function, urine protein, etc.) >20%.
Admission in ICU less than 48 hours.
Patient with psychiatric disorders.
Under 18 years of age.

Accepts Healthy Volunteers

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

Patients who were hospitalized in the ICU of Sun Yat-sen Memorial Hospital of Sun Yat-sen University and met the Sepsis 3 diagnostic criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuewei Li	Contact	020-81332587		liyw7@mail2.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Recruiting	Guangzhou			China

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