Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Phase 4

• Conditions: Kidney Diseases; Diabetes Mellitus; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency
• Interventions: Drug: Alprostadil ﹠control

• Registration Number: NCT01722513
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-03
• Study First Submitted QC: 2012-11-06
• Last Update Submitted: 2012-11-06
• Study First Posted: 2012-11-07
• Last Update Posted: 2012-11-07
• Primary Completion: 2013-11
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alprostadil, Control	Alprostadil ﹠control	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

Primary Outcome Measures

Name	Time	Method
Primary Outcome	72 h	An absolute increase in SCr \>=0.5mg/dL（\>=44.2μmmol/L）or a \>= 25% increase in SCr from baseline to 72h after the procedure

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	30 d	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.

Trial Locations

Locations (1)

Department of Cardiology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China