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

Phase 2

Completed

• Conditions: Renal Insufficiency, Chronic; Coronary Angiography; Angioplasty, Transluminal, Percutaneous Coronary
• Interventions: Drug: Iloprost; Drug: Placebo

• Registration Number: NCT00345501
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-22
• Last Update Posted: 2007-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Iloprost	Iloprost
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl	2-5 days after the procedure
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 Outcome Measures

Name	Time	Method
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups	2-5 days after the procedure

Trial Locations

Locations (1)

Onassis Cardiac Surgery Centre; 🇬🇷 Athens, Greece