Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Nanjing First Hospital, Nanjing Medical University800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

800

Conditions

Diabetes Mellitus Chronic Kidney Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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％)

Outcomes

Primary Outcomes

Contrast-induced nephropathy

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

Time frame: 72 hours

Secondary Outcomes

Major adverse renal events

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.

Time frame: 30 days