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

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

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:
  • Ultravist
Experimental: 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

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

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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