Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

Diabetes Mellitus Clinical Trial

— TRACK-D  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786136
• Other study ID #: SYNH-20081028
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: April 9, 2013
• Start date: December 2008
• Est. completion date: November 2011

Study information

• Verified date: April 2013
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2998
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Diabetes Mellitus
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• rosuvastatin
rosuvastatin

Locations

Country	Name	City	State
China	General Hospital of Liaoning Anshan Iron and Steel Group Corporation	AnShan	Liaoning
China	Chinese People's Liberation Army 252th Hostipal	BaoDing	Hebei
China	Baotou city central hospital	BaoTou
China	Baotou iron and steel group company worker hospital	BaoTou
China	General Hospital Of The Second Artillery Force of the PLA	BeiJing	Beijing
China	Peking University first hospital	Beijing	Beijing
China	The Armed Police General Hospital	BeiJing	Beijing
China	The Chinese people's liberation army general hospital affiliated hospitals	BeiJing	Beijing
China	The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)	BeiJing	Beijing
China	CanZhou Central Hospital	CangZhou	Hebei
China	Changchun Central Hospital	ChangChun	Jilin
China	FAW subsidiary of the General Hospital of Jilin University (Jilin University, Fourth Hospital)	ChangChun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Chengdu Military General Hospital	ChengDu	Sichuan
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	ChongQing	Chongqing
China	The Third Military Medical University, Chongqing Xinqiao Hospital	ChongQing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	DaLian	Liaoning
China	Dongguan Kanghua Hospital	DongGuan	Guangdong
China	Fushun central hospital	FuShun	Liaoning
China	General Hospital of Guangzhou Military Command of PLA	GuangZhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical College	GuangZhou	Guangdong
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	General Hospital of Jinan Military Area Command of Chinese PLA	JiNan	Shandong
China	The First Affiliated Hospital of Liaoning Medical College	Jinzhou	Liaoning
China	Kunming General Hospital of PLA	KunMing	Yunnan
China	The First Affiliated Hospital of Kunming Medical College	KunMing	Yunnan
China	First Hospital of Lanzhou University	LanZhou	Gansu
China	NanJing Drum Tower Hospital	NanJing	Jiangsu
China	Nanjing First Hospital	NanJing	Jiangsu
China	Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University	ShangHai	Shanghai
China	ShenZhou Hopital Of ShenYang Medical College	ShengYang	Liaoning
China	Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine	ShenYang	Liaoning
China	PLA 202 Hospital	ShenYang	Liaoning
China	Shenyang Nortern Hospital	Shenyang	Liaoning
China	The 463th Hospital Of PLA	ShenYang	Liaoning
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Shijiazhuang International Peace Hospital	ShiJiaZhuang	Hebei
China	88th Hospital of the Chinese PLA	TaiAn	Shandong
China	Affiliated Hospital Of Medical College Of The Chinese People's Armed Polic Forces	TianJin	Tianjin
China	PLA 254 Hosipital	TianJin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical College	WenZhou	Zhejiang
China	Renmin Hospital Of Wuhan University	WuHan	Hubei
China	TongJi Medical College HuaZhong University Of Science & Technology	WuHan	Hubei
China	WuHan Asia Heart Hosital	WuHan	Hubei
China	Wuhan General Hospital of Guangzhou Military Area Command of Chinese PLA	WuHan	Hubei
China	WuHan Union Hospital Of China	WuHan	Hubei
China	The First Affilliated Hospital Of Xinjiang Medical University	Wulumuqi	Xinjiang
China	WuluMuqi General Hospital of PLA Lanzhou Military Area Command	WuLuMuQI	Xinjiang
China	Xijing Hospital of the Fourth Military Medical University	XiAn	Shanxi
China	Affiliated Hospital of Ningxia Medical College	Yinchuan	Ningxia
China	HeNan Provincial People's Hospital	ZhengZhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	An absolute increase in SCr >=0.5mg/dL(>=44.2µmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure		72 h	Yes
Secondary	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.		30 d	Yes