Contrast Medium Volume and Contrast-induced Nephropathy A... | NCT01399203

Studies
Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

NCT01399203

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Aug 3, 2011Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Contrast Induced Nephropathy

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 2010

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

Jan 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jul 19, 2011

First Submission Date that Met QC Criteria

Jul 20, 2011

First Posted Date

Jul 21, 2011Estimated

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 2, 2011

Last Update Posted Date

Aug 3, 2011Estimated

Name	Class
Hainan People's Hospital	OTHER
Guangdong Medical College	OTHER

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

To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI

Detailed Description

contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of CIN was assessed using multivariate logistic regression.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
percutaneous coronary intervention		The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contrast-Induced Nephropathy	Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure	48-72 h

Secondary Outcomes

Measure	Description	Time Frame
Major adverse clinical events	Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
provided written informed consent
Creatinine Clearance:15-60ml/min

Exclusion Criteria:

pregnancy
lactation
intravascular administration of an contrast medium within the previous seven days
treatment with metformin
aminoglycosides
N-acetylcysteine (NAC)
nonsteroidal anti-inflammatory drugs within the previous 48 h
intake of nephrotoxic drugs within the previous seven days
history of serious reactions to contrast mediums
severe concomitant disease
renal transplantation , or end-stage renal disease necessitating dialysis patients who died during percutaneous coronary intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning Tan, MD	Contact	86-20-83819161		tanning100@126.com
Yong Liu, MD	Contact	86-15920172292		liuyongyisheng@126.com

Overall Officials

Name	Affiliation	Role
Yong Liu, MD	Guangdong Provincial People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ning Tan	Recruiting	Guangzhou	Guangdong	510100	China