search
Back to results

Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy

Primary Purpose

Radiographic Contrast Agent Nephropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • age > 18 years,
  • chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
  • planned coronary angiography

Exclusion Criteria:

  • chronic utilization of NSAIDS and Cox-2 selective inhibitors,
  • chronic treatment with mineralocorticosteroid receptor blocker, and
  • administration of contrast within 14 days prior to the enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control

    drug stop

    Arm Description

    continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period

    temporary stop of angiotensin converting enzyme inhibitor and angiotensin blocker treatment at least 72 hours before coronary angiography and renew of treatment 72 hours after angiography

    Outcomes

    Primary Outcome Measures

    change in eGFR from baseline to 48-72 hours following the exposure to the contrast.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2012
    Last Updated
    June 4, 2015
    Sponsor
    Soroka University Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01525888
    Brief Title
    Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.
    Detailed Description
    Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    continue with treatment with angiotensin converting enzyme inhibitor or angiotensin blocker during all study period
    Arm Title
    drug stop
    Arm Type
    Experimental
    Arm Description
    temporary stop of angiotensin converting enzyme inhibitor and angiotensin blocker treatment at least 72 hours before coronary angiography and renew of treatment 72 hours after angiography
    Intervention Type
    Procedure
    Intervention Name(s)
    stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
    Intervention Description
    stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker
    Primary Outcome Measure Information:
    Title
    change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
    Time Frame
    48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age > 18 years, chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and planned coronary angiography Exclusion Criteria: chronic utilization of NSAIDS and Cox-2 selective inhibitors, chronic treatment with mineralocorticosteroid receptor blocker, and administration of contrast within 14 days prior to the enrollment.

    12. IPD Sharing Statement

    Learn more about this trial

    Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy

    We'll reach out to this number within 24 hrs