Clinical trial NCT01580046: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
Official title: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Chronic Kidney Disease
Coronary Angiography
Contrast Media
Percutaneous Coronary Intervention
Serum Creatinine
Glomerular Filtration Rate
Iodixanol
Iopromide
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
timeFrame: days 3 and 7
Secondary outcomes:
measure: 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.
timeFrame: days 3 and 7
measure: Incidence of hemodialysis
timeFrame: days 3 and 7
measure: Changes of Cystatin C level from baseline
timeFrame: days 1 and 3
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Academy Of Medical Sciences Guangdong General Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital Of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The People's Hospital Of Hebei Province
state: Hebei
city: Luoyang
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanchang
country: China
facility: The Second Affiliated Hospital To Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: The People's Hospital Of Liaoning Province
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital Of Medical College Qingdao University
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Pla Navy General Hospital
city: Beijing
country: China
facility: The Central Hospital Of China Aerospace Corporation
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chongqing
country: China
facility: Xinqiao Hospital, Third Military Medical University
city: Shanghai
country: China
facility: Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
Study officials:
References: