search
Back to results

Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

Primary Purpose

Kidney Diseases, Diabetes Mellitus, Acute Kidney Injury

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Alprostadil ﹠control
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Contrast Induced Nephropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Department of Cardiology, Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alprostadil, Control

Arm 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

Outcomes

Primary Outcome Measures

Primary Outcome
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

Secondary Outcome
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.

Full Information

First Posted
November 3, 2012
Last Updated
November 6, 2012
Sponsor
Shanghai 10th People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01722513
Brief Title
Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy
Official Title
Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Diabetes Mellitus, Acute Kidney Injury, Kidney Failure, Chronic, Renal Insufficiency
Keywords
Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alprostadil, Control
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Alprostadil ﹠control
Other Intervention Name(s)
Drug: Alprostadil, lipo-alprostadil, Prostaglandin E1, Drug: normal salin
Intervention Description
control:Normal salin 1cc/kg/hr before and after angiography
Primary Outcome Measure Information:
Title
Primary Outcome
Description
An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
Time Frame
72 h
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
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.
Time Frame
30 d

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-Wei Xu, MD, FACC
Organizational Affiliation
Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
10607766
Citation
Koch JA, Plum J, Grabensee B, Modder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. doi: 10.1093/ndt/15.1.43.
Results Reference
result

Learn more about this trial

Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

We'll reach out to this number within 24 hrs