Immune Function Monitoring and Immunotherapy in Sepsis | NCT04903405

Studies
Immune Function Monitoring and Immunotherapy in Sepsis

NCT04903405

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

May 26, 2021Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Sepsis
Septic Shock

Interventions

No intervention

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

May 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

Jun 30, 2021Estimated

Completion Date

Jul 30, 2021Estimated

First Submitted Date

May 23, 2021

First Submission Date that Met QC Criteria

May 23, 2021

First Posted Date

May 26, 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 23, 2021

Last Update Posted Date

May 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.

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

28 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention is involved in this study	Sepsis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality		28 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of sepsis patients receiving immune function monitoring		28 days
Percentage of sepsis patients receiving immunotherapy		28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with sepsis or septic shock according to Sepsis 3.0

Exclusion Criteria:

None

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

The patient was diagnosed with sepsis or septic shock according to Sepsis 3.0

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Wu	Contact	020-87755766-8453		wujianf@mail.sysu.edu.cn
Fei Pei	Contact	020-87755766-8453		peif3@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32636658	Background	Pei F, Zhang GR, Zhou LX, Liu JY, Ma G, Kou QY, He ZJ, Chen MY, Nie Y, Wu JF, Guan XD; China Critical Care Immunotherapy Research Group. Early Immunoparalysis Was Associated with Poor Prognosis in Elderly Patients with Sepsis: Secondary Analysis of the ETASS Study. Infect Drug Resist. 2020 Jun 30;13:2053-2061. doi: 10.2147/IDR.S246513. eCollection 2020.
23327199

ID	Term
D018805	Sepsis
D012772	Shock, Septic

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