Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
NCT ID: NCT01580046
Last Updated: 2013-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2012-04-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Iodixanol
iodixanol
1. coronary angiography, 32gI/100ml, 40～60 ml once injection
2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
iopromide
iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Interventions
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iodixanol
1. coronary angiography, 32gI/100ml, 40～60 ml once injection
2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection
iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Yong Huo
OTHER
Responsible Party
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Yong Huo
MD
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Guangdong Academy Of Medical Sciences Guangdong General Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital Of Hebei Province
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Luoyang, Henan, China
The Second Affiliated Hospital To Nanchang University
Nanchang, Jiangxi, China
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, China
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Peking University People's Hospital
Beijing, , China
Pla Navy General Hospital
Beijing, , China
The Central Hospital Of China Aerospace Corporation
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Xinqiao Hospital, Third Military Medical University
Chongqing, , China
Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
Shanghai, , China
Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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XNK201201
Identifier Type: -
Identifier Source: org_study_id