Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes

Sponsor

Nanjing First Hospital, Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02808351

Collaborator

(none)

800

Enrollment

Location

Arms

Actual Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Chronic Kidney Disease	Drug: Berberine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Berberine
No Intervention: Blank control Blank control of berberine administration

Arm

Intervention/Treatment

Experimental: 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.

Drug: Berberine

No Intervention: Blank control

Blank control of berberine administration

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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％)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

Nanjing First Hospital, Nanjing Medical University

Investigators

Study Chair: Shaoliang Chen, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaoliang Chen, MD, Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital, Nanjing First Hospital, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT02808351

Other Study ID Numbers:

NFH20160611

First Posted:

Jun 21, 2016

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Diabetes Mellitus

Study Results

No Results Posted as of Mar 29, 2022