Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01722513

Enrollment

150

Registered

2012-11-07

Start date

2012-11-30

Completion date

2014-02-28

Last updated

2012-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Contrast Induced Nephropathy

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.

Interventions

DRUGAlprostadil ﹠control

control:Normal salin 1cc/kg/hr before and after angiography

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026