HSPA12B as a Potential Biomarker for Sepsis and Severe Se... | NCT01847248

Studies
HSPA12B as a Potential Biomarker for Sepsis and Severe Sepsis

NCT01847248

Sponsor

Changhai Hospital

Status

Completed

Last Update Posted

Nov 25, 2013Estimated

Enrollment

118Actual

Phase

Not provided

Conditions

Sepsis

Interventions

Not provided

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

May 2, 2013

First Submission Date that Met QC Criteria

May 3, 2013

First Posted Date

May 6, 2013Estimated

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

Nov 22, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Molecules indicating endothelial injury may serve as biomarkers for severe sepsis because of the critical role of endothelial injury in organ dysfunction during severe sepsis.
HSPA12B is primarily located in endothelial cells and detectable during sepsis.
The investigators speculated that HSPA12B from endothelial cells might be correlated with severe 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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sepsis		Patients with sepsis but not severe sepsis
Severe sepsis		Patients with severe sepsis
SIRS		Patients with SIRS after major orthopedics surgery
Control		Healthy volunteers

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-day mortality	mortality within 28 days after recruitment.	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients
Patients meet the diagnostic criteria according to the grouping

Exclusion Criteria:

patients without informed consent
patients who were undergoing continuous renal replacement therapy before sampling
patients with special infection induced by virus, tubercle bacillus, mycoplasma, Chlamydia, and so on

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

Continuous patients with sepsis, severe sepsis, SIRS after major orthopedics surgery and healthy volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ke-ming Zhu, M.D.	Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Medicine, Changhai Hospital		Shanghai		200433	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