Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Diabetes Mellitus

Treatments: Drug: Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT02808351

NFH20160611

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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％)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Berberine

Experimental group

Description:

Preoperative berberine 300 mg administration for at least 6 hours before interventional procedure, post-procedure berberine administration 100 mg at 24, 48 hours after procedure.

Treatment:

Drug: Berberine

Blank control

No Intervention group

Description:

Blank control of berberine administration