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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01399203

Acronym

CONVIN

Enrollment

2000

Registered

2011-07-21

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Nephropathy

Keywords

contrast-induced nephropathy, contrast medium, creatinine clearance, percutaneous coronary intervention

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactNing Tan, MD

tanning100@126.com86-20-83819161

Backup ContactYong Liu, MD

liuyongyisheng@126.com86-15920172292

Outcome results