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Completed

NCT Number: NCT00345501

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

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.

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Key information

Conditions

Renal Insufficiency, Chronic Angioplasty, Transluminal, Percutaneous Coronary Chronic Disease Coronary Angiography Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Onassis Cardiac Surgery Centre

Athens, 17674, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ILOPROST

Drug

Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end

Placebo

Drug

Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups

    Time frame: 2-5 days after the procedure

Sponsors and collaborators

Lead sponsor

Onassis Cardiac Surgery Centre

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Jun 28, 2006
Registry last updated
Aug 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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