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

Renal Insufficiency, Chronic Clinical Trial

Official title:

Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345501
• Other study ID #: OCS IEC 265
• Secondary ID: EudraCT 2005-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 27, 2006
• Last updated: August 22, 2007
• Start date: November 2005
• Est. completion date: July 2007

Study information

• Verified date: August 2007
• Source: Onassis Cardiac Surgery Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Drug Administration of Greece (??F)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Coronary Angiography
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Greece	Onassis Cardiac Surgery Centre	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Onassis Cardiac Surgery Centre

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl		2-5 days after the procedure
Primary	or CMN is defined as a relative rise of at least 25% from baseline on the follow-up		blood sample drawn at 2-5 days after the procedure
Secondary	Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups		2-5 days after the procedure

External Links

•   Hospital Site