- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580046
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)
October 14, 2013 updated by: Yong Huo
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction-a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhaoping Liu, MD
- Phone Number: 86-10-83575727
- Email: dr_liuzhp@yahoo.com.cn
Study Locations
-
-
-
Beijing, China, 100044
- Not yet recruiting
- Peking University People's Hospital
-
Principal Investigator:
- Weimin Wang, MD
-
Beijing, China, 100048
- Recruiting
- Pla Navy General Hospital
-
Principal Investigator:
- Tianchang Li, MD
-
Beijing, China, 100049
- Recruiting
- The Central Hospital of China Aerospace Corporation
-
Principal Investigator:
- Bin Wang, MD
-
Sub-Investigator:
- Tao Qu, MD
-
Sub-Investigator:
- Ying Shen, MD
-
Beijing, China, 100853
- Not yet recruiting
- Chinese PLA General Hospital
-
Principal Investigator:
- Yundai Chen, MD
-
Sub-Investigator:
- Wei Dong, MD
-
Sub-Investigator:
- Sunying Hu, MD
-
Chongqing, China, 400037
- Not yet recruiting
- Xinqiao Hospital, Third Military Medical University
-
Principal Investigator:
- Lan Huang, MD
-
Sub-Investigator:
- Jun Jin, MD
-
Sub-Investigator:
- Yun He, MD
-
Shanghai, China, 200001
- Not yet recruiting
- Renji Hospital ,Shanghai Jiao Tong University School Of Medicine
-
Principal Investigator:
- Ben He, MD
-
Shanghai, China, 200030
- Not yet recruiting
- Shanghai Chest Hospital Affiliated To Shanghai Jiaotong University
-
Principal Investigator:
- Weiyi Fang, MD
-
Shanghai, China, 200080
- Not yet recruiting
- Shanghai First People's Hospital
-
Principal Investigator:
- Shaowen Liu, MD
-
-
Anhui
-
Hefei, Anhui, China, 230001
- Recruiting
- Anhui provincial hospital
-
Principal Investigator:
- Ji Yan, MD
-
Sub-Investigator:
- Kefu Feng, MD
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University First Hospital
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Not yet recruiting
- Fujian Medical University Union Hospital
-
Principal Investigator:
- Lianglong Chen, MD
-
Sub-Investigator:
- Xingchun Zheng, MD
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Not yet recruiting
- Guangdong Academy Of Medical Sciences Guangdong General Hospital
-
Sub-Investigator:
- Yong Liu, MD
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- The First Affiliated Hospital of Guangxi Medical University
-
Principal Investigator:
- Lang Li, MD
-
Sub-Investigator:
- Xiaocong Zeng, MD
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050051
- Not yet recruiting
- The People's Hospital Of Hebei Province
-
Principal Investigator:
- Xiaoyong Qi, MD
-
Sub-Investigator:
- Tianhong Wang, MD
-
-
Henan
-
Luoyang, Henan, China, 450000
- Not yet recruiting
- Henan Provincial People's Hospital
-
Principal Investigator:
- Chuanyu Gao, MD
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- Not yet recruiting
- The Second Affiliated Hospital to Nanchang University
-
Sub-Investigator:
- Yanqing Wu, MD
-
-
Liaoning
-
Shenyang, Liaoning, China, 110016
- Recruiting
- The People's Hospital of Liaoning Province
-
Principal Investigator:
- Zhanquan Li, MD
-
Sub-Investigator:
- Yongxin Wang, MD
-
-
Shandong
-
Qingdao, Shandong, China, 266003
- Not yet recruiting
- The Affiliated Hospital of Medical College Qingdao University
-
Principal Investigator:
- Yi An, MD
-
Sub-Investigator:
- Hua Yu, MD
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030024
- Not yet recruiting
- Shanxi Cardiovascular Hospital
-
Principal Investigator:
- Bao Li, MD
-
Sub-Investigator:
- Zhongchao Wang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: iopromide
|
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8
ml once injection
Other Names:
|
Experimental: Iodixanol
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
Time Frame: days 3 and 7
|
days 3 and 7
|
Secondary Outcome Measures
Outcome 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.
Time Frame: days 3 and 7
|
days 3 and 7
|
Incidence of hemodialysis
Time Frame: days 3 and 7
|
days 3 and 7
|
Changes of Cystatin C level from baseline
Time Frame: days 1 and 3
|
days 1 and 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
April 16, 2012
First Submitted That Met QC Criteria
April 17, 2012
First Posted (Estimate)
April 18, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2013
Last Update Submitted That Met QC Criteria
October 14, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XNK201201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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