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

NCT ID: NCT01399203

Last Updated: 2011-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Contrast Induced Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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percutaneous coronary intervention

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hainan People's Hospital

OTHER

Sponsor Role collaborator

Guangdong Medical College

OTHER

Sponsor Role collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guangdong Cardiovascular Institute,Guangdong General Hospital

Principal Investigators

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Yong Liu, MD

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Locations

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Ning Tan

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Tan, MD

Role: CONTACT

86-20-83819161

Yong Liu, MD

Role: CONTACT

86-15920172292

Facility Contacts

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Ning Tan, MD

Role: primary

8620-83819161

Yong Liu, MD

Role: backup

8615920172292

Other Identifiers

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2009X41

Identifier Type: -

Identifier Source: org_study_id

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