Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Inj... | NCT00819871

Studies
Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery

NCT00819871

Sponsor

Changhai Hospital

Status

Completed

Last Update Posted

May 3, 2013Estimated

Enrollment

105Actual

Phase

Not provided

Conditions

Single Nucleotide Polymorphism
Acute Lung Injury
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

May 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 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 8, 2009

First Submission Date that Met QC Criteria

Jan 8, 2009

First Posted Date

Jan 9, 2009Estimated

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, 2013

Last Update Posted Date

May 3, 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

NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter activity of NFKB1 and several clinical diseases, but the clinical results cannot always be replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this polymorphism remains controversial. This study was performed to investigate the association of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery with CPB.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PLI		patients with postoperative lung injury
without PLI		patients without postoperative lung injury
PLI/PKI		patients with at least one organ injury of lung or kidney after surgery
without PLI/PKI		patients without lung or kidney injury after surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass		24h after cardiac surgery

Secondary Outcomes

Measure	Description	Time Frame
circulating level of CRP, TNF-alpha, IL-10; APACHE Ⅱ score; duration of ICU stay and hospitalization; death in 28 days		one month after cardiac surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese Han unrelated population
undergoing elective cardiac surgery with CPB

Exclusion Criteria:

malignant tumor
autoimmune disease, immunodeficiency or immunosuppressive therapy
chronic renal disease (glomerular filtration rate < 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification>A)
COPD, tuberculosis or other chronic pulmonary diseases
anemia with hemoglobin lower than 90mmHg
bleeding disorders
postoperative pericardial tamponade requiring re-operation
postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

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

Chinese Han patients undergoing elective cardiac surgery with CPB

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital, Second Military Medical University		Shanghai		200433	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19995347	Result	Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. NFKB1-94ins/del polymorphism is not associated with lung injury after cardiopulmonary bypass. Anaesthesia. 2010 Feb;65(2):158-62. doi: 10.1111/j.1365-2044.2009.06186.x. Epub 2009 Nov 25.

ID	Term
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases