Back to resultsIloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
Primary Purpose
Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Iloprost
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Renal Insufficiency, Chronic focused on measuring contrast media, contrast nephropathy
Eligibility Criteria
Inclusion Criteria: Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was <60 ml/min on their most recent sample drawn within 1 month of the planned procedure Exclusion Criteria: Circulatory shock for any reason, systolic blood pressure <95 mm Hg Known acute renal failure End-stage renal disease requiring dialysis Intravascular administration of a contrast medium within the previous 10 days Anticipated re-administration of contrast medium within the following 6 days Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure Primary intervention for acute infarction with ST elevation A procedure performed within 2 h of acute hospital admission
Sites / Locations
- Onassis Cardiac Surgery Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Iloprost
Placebo
Outcomes
Primary Outcome Measures
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
Secondary Outcome Measures
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
Full Information
NCT ID
NCT00345501
First Posted
June 27, 2006
Last Updated
August 22, 2007
Sponsor
Onassis Cardiac Surgery Centre
1. Study Identification
Unique Protocol Identification Number
NCT00345501
Brief Title
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
Official Title
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Onassis Cardiac Surgery Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
Keywords
contrast media, contrast nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Iloprost
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Iloprost
Intervention Description
Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
Primary Outcome Measure Information:
Title
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
Time Frame
2-5 days after the procedure
Title
or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
Time Frame
blood sample drawn at 2-5 days after the procedure
Secondary Outcome Measure Information:
Title
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
Time Frame
2-5 days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was <60 ml/min on their most recent sample drawn within 1 month of the planned procedure
Exclusion Criteria:
Circulatory shock for any reason, systolic blood pressure <95 mm Hg
Known acute renal failure
End-stage renal disease requiring dialysis
Intravascular administration of a contrast medium within the previous 10 days
Anticipated re-administration of contrast medium within the following 6 days
Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure
Primary intervention for acute infarction with ST elevation
A procedure performed within 2 h of acute hospital admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Spargias, MD
Organizational Affiliation
Onassis Cardiac Surgery Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onassis Cardiac Surgery Centre
City
Athens
ZIP/Postal Code
17674
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
19841299
Citation
Spargias K, Adreanides E, Demerouti E, Gkouziouta A, Manginas A, Pavlides G, Voudris V, Cokkinos DV. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation. 2009 Nov 3;120(18):1793-9. doi: 10.1161/CIRCULATIONAHA.109.863159. Epub 2009 Oct 19.
Results Reference
derived
Links:
URL
http://www.onasseio.gr
Description
Hospital Site
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Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
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