Plasma Cystatin C and Acute Kidney Injury | NCT01652755

Studies
Plasma Cystatin C and Acute Kidney Injury

NCT01652755

Sponsor

Jinhua Central Hospital

Status

Unknown status

Last Update Posted

Aug 6, 2012Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

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

Aug 2012

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

Apr 2011

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Jul 26, 2012

First Submission Date that Met QC Criteria

Jul 27, 2012

First Posted Date

Jul 30, 2012Estimated

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

Aug 3, 2012

Last Update Posted Date

Aug 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

To evaluate the utility of plasma cystatin C(pCysC) as a predictive and diagnostic marker of acute kidney injury(AKI) in patients undergone cardiopulmonary bypass surgery.

Detailed Description

This is a prospective AKI observational study in patients undergone cardiopulmonary bypass surgery. pCysC and plasma creatine will be measured at entry to ICU.AKI was defined as 50% increase in plasma creatine above baseline.The predictive and diagnostic performance of pCysC will be assessed from area under receiver operator characteristic curve(AUC) and odds ratio(OR).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AKI group		patients with AKI after cardiopulmonary bypass surgery
non-AKI group		patients without AKI during study period

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with CPB and admitted to ICU

Exclusion Criteria:

patients with the age >80 or <18 years
with preexisting renal dysfunction

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 undergone cardiopulmonary bypass surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hongying Ni, MM	Contact	86	57982552629	nihongying2@163.com

Overall Officials

Name	Affiliation	Role
Hongying Ni, MM	Jinhua Municipal Central Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinhua central hospital	Recruiting	Jinhua	Zhejiang	321000	China

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided