The Correlation Between Oxidative Stress and Indinated Co... | NCT00632892

Studies
The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity

NCT00632892

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Mar 11, 2008Estimated

Enrollment

Phase

Not provided

Conditions

Kidney Diseases

Interventions

Not provided

Countries

Taiwan

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

Feb 2008

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

Dec 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Not provided

First Submitted Date

Mar 3, 2008

First Submission Date that Met QC Criteria

Mar 10, 2008

First Posted Date

Mar 11, 2008Estimated

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

Mar 10, 2008

Last Update Posted Date

Mar 11, 2008Estimated

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

Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists.

The present study is aimed to determine the norepinephrine concentration, oxidative markers, and tubular damage markers in the urine samples of patients undergoing intravenous pyelography (IVP).

The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress and greater tubular damage than iso-osmolarity contrast media (IOCM).

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (> 18 years old)
Undergoing IVP with an appropriate medical indication
Signing informed consent

Exclusion Criteria:

1. Without signing informed consent

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

Adult patients (> 18 years old)
Undergoing IVP with an appropriate medical indication
Signing informed consent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Pan Chiao, Taipei		220	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided