Chronic Kidney Disease, Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, chronic kidney disease, contrast induced acute kidney injury, angiography
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.
Interventions
DRUGrosuvastatin
rosuvastatin
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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％)
Design outcomes
Primary
| 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 | 72 h |
Secondary
| 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. | 30 d |
Countries
China
Outcome results
None listed