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

August 22, 2007 updated by: Onassis Cardiac Surgery Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17674
        • Onassis Cardiac Surgery Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
Experimental: 1
Iloprost
Drug: Iloprost
Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2-5 days after the procedure
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
blood sample drawn at 2-5 days after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
Time Frame: 2-5 days after the procedure
2-5 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onassis Cardiac Surgery Centre

Investigators

  • Principal Investigator: Konstantinos Spargias, MD, Onassis Cardiac Surgery Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Estimate)

August 24, 2007

Last Update Submitted That Met QC Criteria

August 22, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCS IEC 265
  • EudraCT 2005-001887-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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