Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes (TRACK-D)

April 9, 2013 updated by: Han Yaling, MD, Shenyang Northern Hospital

Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2998

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 Locations

  • China
      • BaoTou, China, 014000
        • Baotou City Central Hospital
      • BaoTou, China, 014040
        • Baotou iron and steel group company worker hospital
    • Beijing
      • BeiJing, Beijing, China, 100000
        • The Armed Police General Hospital
      • BeiJing, Beijing, China, 100000
        • The Chinese people's liberation army general hospital affiliated hospitals
      • BeiJing, Beijing, China, 100088
        • General Hospital Of The Second Artillery Force of the PLA
      • BeiJing, Beijing, China, 100853
        • The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
      • Beijing, Beijing, China, 100034
        • Peking University first hospital
    • Chongqing
      • ChongQing, Chongqing, China, 400037
        • The Third Military Medical University, Chongqing Xinqiao Hospital
      • ChongQing, Chongqing, China, 400042
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    • Gansu
      • LanZhou, Gansu, China, 730000
        • First Hospital of Lanzhou University
    • Guangdong
      • DongGuan, Guangdong, China, 523080
        • Dongguan Kanghua Hospital
      • GuangZhou, Guangdong, China, 510010
        • General Hospital of Guangzhou Military Command of PLA
      • GuangZhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical College
    • Hebei
      • BaoDing, Hebei, China, 610000
        • Chinese People's Liberation Army 252th Hostipal
      • CangZhou, Hebei, China, 610001
        • CanZhou Central Hospital
      • ShiJiaZhuang, Hebei, China, 600082
        • Shijiazhuang International Peace Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • The Second Affiliated Hospital of Harbin Medical University
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • ZhengZhou, Henan, China
        • Henan Provincial People's Hospital
    • Hubei
      • WuHan, Hubei, China, 430022
        • WuHan Asia Heart Hosital
      • WuHan, Hubei, China, 430022
        • Wuhan Union Hospital of China
      • WuHan, Hubei, China, 430030
        • Tongji Medical College Huazhong University of Science & Technology
      • WuHan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • WuHan, Hubei, China, 430070
        • Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
    • Jiangsu
      • NanJing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • NanJing, Jiangsu, China, 210008
        • Nanjing Drum Tower hospital
    • Jilin
      • ChangChun, Jilin, China, 130011
        • FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
      • ChangChun, Jilin, China, 130051
        • Changchun Central Hospital
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
    • Liaoning
      • AnShan, Liaoning, China, 114001
        • General Hospital of Liaoning Anshan Iron and Steel Group Corporation
      • DaLian, Liaoning, China, 116001
        • Affiliated Zhongshan Hospital of Dalian University
      • FuShun, Liaoning, China, 113006
        • Fushun central hospital
      • Jinzhou, Liaoning, China, 121001
        • The first affiliated hospital of Liaoning medical college
      • ShenYang, Liaoning, China, 110004
        • PLA 202 Hospital
      • ShenYang, Liaoning, China, 110032
        • Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
      • ShenYang, Liaoning, China, 110042
        • The 463th Hospital Of PLA
      • ShengYang, Liaoning, China, 110032
        • ShenZhou Hopital Of ShenYang Medical College
      • Shenyang, Liaoning, China, 110016
        • Shenyang Nortern Hospital
      • Shenyang, Liaoning, China, 110032
        • the Fourth Affiliated Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Affiliated Hospital of Ningxia Medical College
    • Shandong
      • JiNan, Shandong, China, 250031
        • General Hospital of Jinan Military Area Command of Chinese PLA
      • TaiAn, Shandong, China, 271000
        • 88th Hospital of the Chinese PLA
    • Shanghai
      • ShangHai, Shanghai, China, 200025
        • Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
    • Shanxi
      • XiAn, Shanxi, China, 710032
        • Xijing Hospital of the Fourth Military Medical University
    • Sichuan
      • ChengDu, Sichuan, China, 610083
        • Chengdu Military General Hospital
    • Tianjin
      • TianJin, Tianjin, China, 300142
        • PLA 254 Hosipital
      • TianJin, Tianjin, China, 300162
        • Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
    • Xinjiang
      • WuLuMuQI, Xinjiang, China, 830000
        • WuluMuqi General Hospital of PLA Lanzhou Military Area Command
      • Wulumuqi, Xinjiang, China, 830054
        • The First Affilliated Hospital Of Xinjiang Medical University
    • Yunnan
      • KunMing, Yunnan, China, 650031
        • The First Affiliated Hospital of Kunming Medical College
      • KunMing, Yunnan, China, 650032
        • Kunming General Hospital of PLA
    • Zhejiang
      • WenZhou, Zhejiang, China, 325000
        • The First Affiliated Hospital Of WenZhou Medical College

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:

  • Planned diagnostic coronary or peripheral artery angiography
  • T2DM
  • CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
  • Statin naive, or not on statin treatment for at least 14 days
  • Withdrawal metformin or aminophylline for 48h before angiography
  • Total iodixanol volume

Exclusion Criteria:

  • Hypersensitivity to iodine-containing compounds and statins
  • Type 1 diabetes mellitus
  • Ketoacidosis
  • Lactic acidosis
  • CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
  • STEMI
  • NYHA class IV or hemodynamic instability
  • Administration of any iodinated CM within 14 days before randomization
  • LDL-C<1.82mmol/L（70mg/dL）
  • Hepatic dysfunction (ALT 3 times greater than upper normal limit)
  • Thyreoid insufficiency
  • renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)

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
Experimental: 1
perioperative rosuvastatin administration for at least 5 dosages
Drug: rosuvastatin
rosuvastatin
Placebo Comparator: control
blank control of perioperative statin administration
Drug: rosuvastatin
rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
Time Frame: 72 h
72 h

Secondary Outcome Measures

Outcome Measure
Time Frame
The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.
Time Frame: 30 d
30 d

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNH-20081028

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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