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Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01722513
Collaborator
(none)
150
Enrollment
1
Location
1
Arm
15
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alprostadil ﹠control
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Study Start Date :
Nov 1, 2012
Anticipated Primary Completion Date :
Nov 1, 2013
Anticipated Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Alprostadil ﹠control
control:Normal salin 1cc/kg/hr before and after angiography
Other Names:
  • Drug: Alprostadil
  • lipo-alprostadil
  • Prostaglandin E1
  • Drug: normal salin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardiology, Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    • Principal Investigator: Ya-Wei Xu, MD, FACC, Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ya-Wei Xu, MD FACC, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT01722513
    Other Study ID Numbers:
    • NCT20120312
    First Posted:
    Nov 7, 2012
    Last Update Posted:
    Nov 7, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Ya-Wei Xu, MD FACC, Shanghai 10th People's Hospital
    Contrast Induced Nephropathy
    Additional relevant MeSH terms:
    Kidney Diseases
    Acute Kidney Injury
    Renal Insufficiency
    Kidney Failure, Chronic
    Alprostadil

    Study Results

    No Results Posted as of Nov 7, 2012