Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient

Conditions
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Diabetes Mellitus, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Berberine


Participation Criteria
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Eligibility Criteria
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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％)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Berberine<br>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. | Drug: Berberine<br> <br> |
| No Intervention: Blank control<br>Blank control of berberine administration | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days |