Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00345501
Recruitment Status : Completed
First Posted : June 28, 2006
Last Update Posted : August 24, 2007
Information provided by:
Onassis Cardiac Surgery Centre

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Coronary Angiography Angioplasty, Transluminal, Percutaneous Coronary Drug: Iloprost Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
Study Start Date : November 2005
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Iloprost

Arm Intervention/treatment
Experimental: 1
Drug: Iloprost
Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end

Placebo Comparator: 2
Drug: Placebo
Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups [ Time Frame: 2-5 days after the procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00345501

Onassis Cardiac Surgery Centre
Athens, Greece, 17674
Sponsors and Collaborators
Onassis Cardiac Surgery Centre
Principal Investigator: Konstantinos Spargias, MD Onassis Cardiac Surgery Centre

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00345501     History of Changes
Other Study ID Numbers: OCS IEC 265
EudraCT 2005-001887-30
First Posted: June 28, 2006    Key Record Dates
Last Update Posted: August 24, 2007
Last Verified: August 2007

Keywords provided by Onassis Cardiac Surgery Centre:
contrast media
contrast nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents