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

This study has been completed.
Information provided by:
Onassis Cardiac Surgery Centre Identifier:
First received: June 27, 2006
Last updated: August 22, 2007
Last verified: August 2007

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 Intervention Phase
Renal Insufficiency, Chronic
Coronary Angiography
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Iloprost
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Onassis Cardiac Surgery Centre:

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

Enrollment: 208
Study Start Date: November 2005
Study Completion Date: July 2007
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00345501

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

Additional Information:
No publications provided by Onassis Cardiac Surgery Centre

Additional 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
Study First Received: June 27, 2006
Last Updated: August 22, 2007
Health Authority: Greece: National Drug Administration of Greece (ΕΟΦ)

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents processed this record on April 20, 2014