NCT00345501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 24, 2007

Status Verified

August 1, 2007

First QC Date

June 27, 2006

Last Update Submit

August 22, 2007

Conditions

Renal Insufficiency, ChronicCoronary AngiographyAngioplasty, Transluminal, Percutaneous Coronary

Keywords

contrast mediacontrast nephropathy

Outcome Measures

Primary Outcomes (2)

  • CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl

    2-5 days after the procedure

  • or CMN is defined as a relative rise of at least 25% from baseline on the follow-up

    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

    2-5 days after the procedure

Study Arms (2)

1

EXPERIMENTAL

Iloprost

Drug: Iloprost

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IloprostDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onassis Cardiac Surgery Centre

Athens, 17674, Greece

Location

Related Publications (1)

  • 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.

    PMID: 19841299DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Konstantinos Spargias, MD

    Onassis Cardiac Surgery Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

November 1, 2005

Study Completion

July 1, 2007

Last Updated

August 24, 2007

Record last verified: 2007-08

Locations

GR(1)