Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Diabetes Mellitus Clinical Trial

Official title:

Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01722513
• Other study ID #: NCT20120312
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 3, 2012
• Last updated: November 6, 2012
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: November 2012
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Description:

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 aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient that underwent coronary angiography

• T2DM

• CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2

• Alprostadil naive, or not on Alprostadil treatment for at least 14 days

• Withdrawal metformin or aminophylline for 48h before angiography

Exclusion Criteria:

• serum Cr. More than 3 mg/dl

• electrolyte and acid-base imbalance

• pulmonary edema

• allergy to Alprostadil

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Diabetes Mellitus
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Alprostadil ?control
control:Normal salin 1cc/kg/hr before and after angiography

Locations

Country	Name	City	State
China	Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Koch JA, Plum J, Grabensee B, Mödder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	An absolute increase in SCr >=0.5mg/dL(>=44.2µmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure	72 h	Yes
Secondary	Secondary Outcome	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 d	Yes

External Links

•   Shanghai Tenth People's Hospital
•   State Food and Drug Administration ,China