Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

NCT ID: NCT02808351

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-12-31

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.

Conditions

Diabetes Mellitus; Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Berberine

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.

Group Type: EXPERIMENTAL

Berberine

Intervention Type: DRUG

Blank control

Blank control of berberine administration

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Berberine

Intervention Type: DRUG

Eligibility Criteria

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％)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen, MD

Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaoliang Chen

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NFH20160611

Identifier Type: -

Identifier Source: org_study_id