Overview

This trial is active, not recruiting.

Conditions kidney diseases, diabetes mellitus, acute kidney injury, kidney failure, chronic, renal insufficiency
Treatment alprostadil ﹠control
Phase phase 4
Sponsor Shanghai 10th People's Hospital
Start date November 2012
End date November 2013
Trial size 150 participants
Trial identifier NCT01722513, NCT20120312

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
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
alprostadil ﹠control Drug: Alprostadil
control:Normal salin 1cc/kg/hr before and after angiography

Primary Outcomes

Measure
Primary Outcome
time frame: 72 h

Secondary Outcomes

Measure
Secondary Outcome
time frame: 30 d

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Principal investigator Ya-Wei Xu, MD, FACC
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Shanghai 10th People's Hospital.