Clinical trial NCT00345501: Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
Official title: Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Insufficiency, Chronic
Coronary Angiography
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: contrast media
contrast nephropathy
Lead sponsor: Onassis Cardiac Surgery Centre
Sponsor class: OTHER
First posted: 2006-06-28
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
timeFrame: 2-5 days after the procedure
measure: or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
timeFrame: blood sample drawn at 2-5 days after the procedure
Secondary outcomes:
measure: Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
timeFrame: 2-5 days after the procedure
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Centre
Study officials:
affiliation: Onassis Cardiac Surgery Centre
name: Konstantinos Spargias, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spargias K, Adreanides E, Demerouti E, Gkouziouta A, Manginas A, Pavlides G, Voudris V, Cokkinos DV. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation. 2009 Nov 3;120(18):1793-9. doi: 10.1161/CIRCULATIONAHA.109.863159. Epub 2009 Oct 19.