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

NCT ID: NCT00345501

Last Updated: 2007-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Renal Insufficiency, Chronic Coronary Angiography Angioplasty, Transluminal, Percutaneous Coronary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Iloprost

Group Type EXPERIMENTAL

Iloprost

Intervention Type DRUG

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Iloprost

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Onassis Cardiac Surgery Centre

OTHER

Sponsor Role lead

Principal Investigators

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Konstantinos Spargias, MD

Role: PRINCIPAL_INVESTIGATOR

Onassis Cardiac Surgery Centre

Locations

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Onassis Cardiac Surgery Centre

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 19841299 (View on PubMed)

Related Links

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http://www.onasseio.gr

Hospital Site

Other Identifiers

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EudraCT 2005-001887-30

Identifier Type: -

Identifier Source: secondary_id

OCS IEC 265

Identifier Type: -

Identifier Source: org_study_id