Multiple Biomarkers in ICU Sepsis Patients | NCT03802136

Studies
Multiple Biomarkers in ICU Sepsis Patients

NCT03802136

Sponsor

Zhongnan Hospital

Status

Unknown status

Last Update Posted

Jan 14, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Sepsis, Severe
Sepsis
Septic Shock
AKI

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

Jan 2019

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

Dec 30, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 11, 2019

First Posted Date

Jan 14, 2019Actual

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

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

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

Detailed Description

Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening of renal function. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining functional and damage markers as well as oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients. Therefore, this prospective, observational study will be conducted in Mainland China

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high concentration of biomarkers		the patients with biomarkers level over the normal max value
low concentration of biomarkers		the patients with biomarkers level below the normal max value

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of AKI	Use serum creatinine or urine output（The KDIGO Guidelines 2012) to asess whether AKI happens to the studied subjects within a week after admission to ICU	a week after admission to ICU
Death of the patients	Mortality of the studied patients	2 weeks after admission to ICU

Secondary Outcomes

Measure	Description	Time Frame
Use serum creatinine to assess renal function of the patients	Concetration of serum creatinine	the 1 day when the patients admitted to ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sepsis patients in appropriate age

Exclusion Criteria:

ever blood transfusion ever CPR（cardiopulmonary resuscitation)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients admitted to ICU of Zhongnan Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
zhiyong peng, professor	Contact	008618672396028		pengzy5@hotmail.com
Li He	Contact	008617798258617		helisoul@163.com

Overall Officials

Name	Affiliation	Role
zhiyong peng, professor	Zhongnan Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongnan Hospital of Wuhan University	Recruiting	Wuhan	Hubei	430000	China

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided