Kidney Failure, Chronic
Conditions
Keywords
Chronic Kidney Disease, Coronary Angiography, Contrast Media, Percutaneous Coronary Intervention, Serum Creatinine, Glomerular Filtration Rate, Iodixanol, Iopromide
Brief summary
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
Detailed description
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.
Interventions
Sponsors
Yong Huo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate | days 3 and 7 |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactZhaoping Liu, MD
Outcome results
None listed