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Statins for Prevention of Contrast Induced Nephropathy

Primary Purpose

Contrast Induced Nephropathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
Ospedale Misericordia e Dolce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast induced nephropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with pre-angiographic estimated creatinine clearance < 60 ml/min

Exclusion Criteria:

  • contrast medium administration within the previous 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent
  • previous therapy with statin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Atorvastatin

    Arm Description

    placebo

    80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.

    Outcomes

    Primary Outcome Measures

    Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards

    Secondary Outcome Measures

    Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
    Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

    Full Information

    First Posted
    October 9, 2008
    Last Updated
    October 15, 2015
    Sponsor
    Ospedale Misericordia e Dolce
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00770796
    Brief Title
    Statins for Prevention of Contrast Induced Nephropathy
    Official Title
    Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ospedale Misericordia e Dolce

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Contrast Induced Nephropathy
    Keywords
    Contrast induced nephropathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    304 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Arm Title
    Atorvastatin
    Arm Type
    Active Comparator
    Arm Description
    80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after.
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin
    Intervention Description
    80 mg die
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards
    Time Frame
    within 5 days after contrast exposure
    Secondary Outcome Measure Information:
    Title
    Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration
    Time Frame
    within 5 days after contrast agent administration
    Title
    Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with pre-angiographic estimated creatinine clearance < 60 ml/min Exclusion Criteria: contrast medium administration within the previous 10 days end-stage renal failure requiring dialysis refusal to give informed consent previous therapy with statin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro Maioli, MD
    Organizational Affiliation
    Ospedale Misericordia e Dolce, Prato
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Statins for Prevention of Contrast Induced Nephropathy

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