Clinical trial NCT00786136: Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
Official title: Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Chronic Kidney Disease
Keywords: diabetes mellitus
chronic kidney disease
contrast induced acute kidney injury
angiography
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 2998
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 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.


Eligibility criteria: 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％)

Primary outcomes:
measure: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
timeFrame: 72 h
Secondary outcomes:
measure: 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.
timeFrame: 30 d
Other outcomes:
Locations:
city: BeiJing
country: China
facility: The Armed Police General Hospital
state: Beijing
city: BeiJing
country: China
facility: The Chinese people's liberation army general hospital affiliated hospitals
state: Beijing
city: Beijing
country: China
facility: Peking University first hospital
state: Beijing
city: BeiJing
country: China
facility: General Hospital Of The Second Artillery Force of the PLA
state: Beijing
city: BeiJing
country: China
facility: The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
state: Beijing
city: ChongQing
country: China
facility: The Third Military Medical University, Chongqing Xinqiao Hospital
state: Chongqing
city: ChongQing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
city: LanZhou
country: China
facility: First Hospital of Lanzhou University
state: Gansu
city: DongGuan
country: China
facility: Dongguan Kanghua Hospital
state: Guangdong
city: GuangZhou
country: China
facility: General Hospital of Guangzhou Military Command of PLA
state: Guangdong
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: BaoDing
country: China
facility: Chinese People's Liberation Army 252th Hostipal
state: Hebei
city: CangZhou
country: China
facility: CanZhou Central Hospital
state: Hebei
city: ShiJiaZhuang
country: China
facility: Shijiazhuang International Peace Hospital
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: ZhengZhou
country: China
facility: HeNan Provincial People's Hospital
state: Henan
city: WuHan
country: China
facility: WuHan Asia Heart Hosital
state: Hubei
city: WuHan
country: China
facility: WuHan Union Hospital Of China
state: Hubei
city: WuHan
country: China
facility: TongJi Medical College HuaZhong University Of Science & Technology
state: Hubei
city: WuHan
country: China
facility: Renmin Hospital Of Wuhan University
state: Hubei
city: WuHan
country: China
facility: Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA
state: Hubei
city: NanJing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: NanJing
country: China
facility: NanJing Drum Tower Hospital
state: Jiangsu
city: ChangChun
country: China
facility: FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: ChangChun
country: China
facility: Changchun Central Hospital
state: Jilin
city: AnShan
country: China
facility: General Hospital of Liaoning Anshan Iron and Steel Group Corporation
state: Liaoning
city: DaLian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: FuShun
country: China
facility: Fushun central hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Liaoning Medical College
state: Liaoning
city: ShengYang
country: China
facility: ShenZhou Hopital Of ShenYang Medical College
state: Liaoning
city: ShenYang
country: China
facility: PLA 202 Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Nortern Hospital
state: Liaoning
city: ShenYang
country: China
facility: Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
state: Liaoning
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
state: Liaoning
city: ShenYang
country: China
facility: The 463th Hospital Of PLA
state: Liaoning
city: Yinchuan
country: China
facility: Affiliated Hospital of Ningxia Medical College
state: Ningxia
city: JiNan
country: China
facility: General Hospital of Jinan Military Area Command of Chinese PLA
state: Shandong
city: TaiAn
country: China
facility: 88th Hospital of the Chinese PLA
state: Shandong
city: ShangHai
country: China
facility: Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University
state: Shanghai
city: XiAn
country: China
facility: Xijing Hospital of the Fourth Military Medical University
state: Shanxi
city: ChengDu
country: China
facility: Chengdu Military General Hospital
state: Sichuan
city: TianJin
country: China
facility: PLA 254 Hosipital
state: Tianjin
city: TianJin
country: China
facility: Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces
state: Tianjin
city: WuLuMuQI
country: China
facility: WuluMuqi General Hospital of PLA Lanzhou Military Area Command
state: Xinjiang
city: Wulumuqi
country: China
facility: The First Affilliated Hospital Of Xinjiang Medical University
state: Xinjiang
city: KunMing
country: China
facility: The First Affiliated Hospital of Kunming Medical College
state: Yunnan
city: KunMing
country: China
facility: Kunming General Hospital of PLA
state: Yunnan
city: WenZhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: BaoTou
country: China
facility: Baotou city central hospital
city: BaoTou
country: China
facility: Baotou iron and steel group company worker hospital
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Li Y, Wang X, Yang S, Gao C, Zhang Z, Yang C, Jing Q, Wang S, Ma Y, Wang Z, Liang Y, Han Y. Age, estimated glomerular filtration rate and ejection fraction score predicts contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease: insight from the TRACK-D study. Chin Med J (Engl). 2014;127(12):2332-6.
citation: Han Y, Zhu G, Han L, Hou F, Huang W, Liu H, Gan J, Jiang T, Li X, Wang W, Ding S, Jia S, Shen W, Wang D, Sun L, Qiu J, Wang X, Li Y, Deng J, Li J, Xu K, Xu B, Mehran R, Huo Y. Short-term rosuvastatin therapy for prevention of contrast-induced acute kidney injury in patients with diabetes and chronic kidney disease. J Am Coll Cardiol. 2014 Jan 7-14;63(1):62-70. doi: 10.1016/j.jacc.2013.09.017. Epub 2013 Sep 26.