Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes
- Registration Number
- NCT00786136
- Lead Sponsor
- Shenyang Northern Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2998
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 rosuvastatin perioperative rosuvastatin administration for at least 5 dosages control rosuvastatin blank control of perioperative statin administration
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (53)
The Armed Police General Hospital
🇨🇳BeiJing, Beijing, China
The Chinese people's liberation army general hospital affiliated hospitals
🇨🇳BeiJing, Beijing, China
Peking University first hospital
🇨🇳Beijing, Beijing, China
General Hospital Of The Second Artillery Force of the PLA
🇨🇳BeiJing, Beijing, China
The General Hospital of the People's Liberation Army (PLAGH) ( Hospital 301)
🇨🇳BeiJing, Beijing, China
The Third Military Medical University, Chongqing Xinqiao Hospital
🇨🇳ChongQing, Chongqing, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳ChongQing, Chongqing, China
First Hospital of Lanzhou University
🇨🇳LanZhou, Gansu, China
Dongguan Kanghua Hospital
🇨🇳DongGuan, Guangdong, China
General Hospital of Guangzhou Military Command of PLA
🇨🇳GuangZhou, Guangdong, China
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