Chronic Kidney Disease, Diabetes Mellitus
Conditions
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 nephropathy (CIN). Major risk factors for CIN 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 berberine treatment during and after the perioperative period would reduce the risk of CIN in a high-risk population of patients with both DM and CKD undergoing coronary angiography or noncoronary angiography, and the influence of such potential benefit on short-term outcome.
Interventions
DRUGBerberine
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned diagnostic coronary or peripheral artery angiography * Type 2 diabetes mellitus * CKD stages ≥2 * 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 berberine * Ketoacidosis * Lactic acidosis * CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR\<15ml/min per 1.73m2) * STEMI * NYHA class IV or hemodynamic instability * Administration of any iodinated contrast medium 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 | Description |
|---|---|---|
| Contrast-induced nephropathy | 72 hours | An absolute increase in serum creatinine (SCr) \>=0.5mg/dL（\>=44.2μmmol/L）or a \>= 25% increase in SCr from baseline to 72 hours after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse renal events | 30 days | 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. |
Countries
China
Outcome results
None listed