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

Onassis Cardiac Surgery Centre

Status and phase

Completed

Phase 3

Phase 2

Conditions

Coronary Angiography

Angioplasty, Transluminal, Percutaneous Coronary

Renal Insufficiency, Chronic

Treatments

Drug: Iloprost

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00345501

EudraCT 2005-001887-30

OCS IEC 265

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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