Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Tongji University

Status and phase: Unknown; Phase 4

Conditions: Kidney Diseases; Acute Kidney Injury; Diabetes Mellitus; Renal Insufficiency; Kidney Failure, Chronic

Treatments: Drug: Alprostadil ﹠control

Study type: Interventional

Funder types: Other

Identifiers

NCT01722513

NCT20120312

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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150 participants in 1 patient group

Alprostadil, Control

Experimental group

Description:

Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography

Treatment:

Drug: Alprostadil ﹠control