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PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio

Completed
Conditions
Contrast Induced Nephropathy
Registration Number
NCT01400295
Lead Sponsor
Guangdong Provincial People's Hospital
Brief Summary

To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography

Detailed Description

Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. 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 contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance \< 60 ml/min,diabetes,emergent angiography.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
3000
Inclusion Criteria
  • patients who agreed to stay in the hospital for 2-3 days after coronary angiography
  • provided written informed consent
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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 coronary angiography
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Contrast-Induced Nephropathy48-72 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
NameTimeMethod
Major adverse clinical events1month

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

An early abnormal increase in serum creatinine24h

An early abnormal increase in serum creatinine defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 24h of contrast exposure

An early abnormal increase in serum cystatin C24h

An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure

Trial Locations

Locations (1)

Guangdong Cardiovascular Institute,Guangdong General Hospital

🇨🇳

Guangzhou, Guangdong, China

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