Construction of a Database for the Life-cycle Sepsis-spec... | NCT04872010

Studies
Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

NCT04872010

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

May 4, 2021Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

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

Apr 2021

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

Jun 1, 2021Estimated

Primary Completion Date

Sep 30, 2022Estimated

Completion Date

Sep 30, 2022Estimated

First Submitted Date

Apr 10, 2021

First Submission Date that Met QC Criteria

May 2, 2021

First Posted Date

May 4, 2021Actual

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 2, 2021

Last Update Posted Date

May 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shuming Pan, Deputy Dean of Xinhua Hospital, Leader of Emergency Medicine Science Department, Xinhua Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

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

Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.

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

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

4,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sepsis organ function status and survival analysis.	Safety indicators include: prognosis: mortality, intensive care unit (ICU) treatment time and hospital stay, incidence of nosocomial infections, treatment-related complications.	2022.09.30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;
It is estimated that the patient's ICU stay ≥24 hours;
Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

The patient's ICU hospital stay is less than 24 hours;
Participated in other clinical research;
Failed to sign the informed consent form.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

1-100 years

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

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