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

• Conditions: Contrast Induced Nephropathy

• Registration Number: NCT01399203
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03
• Primary Completion: 2011-10
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast-Induced Nephropathy	48-72 h	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

Secondary Outcome Measures

Name	Time	Method
Major adverse clinical events	1 year	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

Trial Locations

Locations (1)

Ning Tan; 🇨🇳 Guangzhou, Guangdong, China