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

Contrast Induced Nephropathy Clinical Trial

— CONVIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01399203
• Other study ID #: 2009X41
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2011
• Last updated: August 2, 2011
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2010
• Source: Guangdong General Hospital
• Contact: Ning Tan, MD
• Phone: 86-20-83819161
• Email: tanning100[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
China	Ning Tan	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangdong General Hospital	Guangdong Medical College, Hainan People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes