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

This study has been completed.
Sponsor:
Information provided by:
Onassis Cardiac Surgery Centre
ClinicalTrials.gov Identifier:
NCT00345501
First received: June 27, 2006
Last updated: August 22, 2007
Last verified: August 2007
History of Changes
  Purpose

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:

Drug Information available for: Iloprost
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345501

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

Additional Information:
Hospital Site  This link exits the ClinicalTrials.gov site

No publications provided by Onassis Cardiac Surgery Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
Iloprost
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013