Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

Detailed Description
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The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.

Official Title
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Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Drug: iodixanol
* Drug: iopromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides written Informed Consent and is willing to comply with protocol requirements Is referred for cardiac angiography, with or without PCI Has a documented predose serum creatinine level of 1.5～3.5 mg/dl for men and 1.3～3.0 mg/dl for women Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment) Exclusion Criteria: Has a history of hypersensitivity to iodine-containing compounds Has end-stage renal disease Has kidney transplantation Has creatinine clearance rates >60 ml/min in last 3 months Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock Patients with cancer Has diabetes with serious complications, other kidney organs Patients with serious blood system disease Heart failure [class III Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema] Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit] Has received an iodinated contrast agent within 14 days prior to the administration of the study agent Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ] Uncontrolled condition of hyperthyroidism pregnancy or lactation Is planned to receive the drugs without permission in this protocol Participating in another intervention research study in last 3 months legally incapacitated or limitations Any other conditions not suitable to be enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodixanol<br> | Drug: iodixanol<br>* coronary angiography, 32gI/100ml, 40～60 ml once injection left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection<br>|
| Active Comparator: iopromide<br> | Drug: iopromide<br>* coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection<br>* Other names: Ultravist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate |  | days 3 and 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10% 25%, and ≥25%), comparing with baseline level. |  | days 3 and 7 | 
| Incidence of hemodialysis |  | days 3 and 7 | 
| Changes of Cystatin C level from baseline |  | days 1 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Coronary Angiography, Contrast Media, Percutaneous Coronary Intervention, Serum Creatinine, Glomerular Filtration Rate, Iodixanol, Iopromide