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A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

Primary Purpose

Kidney Diseases, Contrast Media Reaction

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sodium bicarbonate
N-acetylcysteine
Sponsored by
Clinical Hospital Centre Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Diseases focused on measuring Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen

Eligibility Criteria

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

Inclusion Criteria:

  • angina (stable, unstable)
  • coronary artery disease
  • cardiomyopathy
  • valvular disease
  • vasculitis
  • peripheral arterial disease

Exclusion Criteria:

  • kidney dysfunction
  • uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg)
  • pregnancy
  • lactation
  • history of allergic reaction to contrast agents
  • cardiogenic shock
  • pulmonary edema
  • multiple myeloma
  • urgent coronary angiography
  • receiving contrast agents two days prior to the study and 48 hours within the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    control

    Sodium bicarbonate

    N-acetylcysteine plus Sodium bicarbonate

    Arm Description

    perorally 1500 ml water on the day of the procedure

    3 mL/kg/hour IV (in vein) of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography

    N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Sodium bicarbonate solution on the day of the angiography.

    Outcomes

    Primary Outcome Measures

    renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
    measure of serum creatinine before and after diagnostic procedure

    Secondary Outcome Measures

    blood urea nitrogen in mmol/L
    measure of blood urea nitrogen before and after diagnostic procedure
    neutrophil gelatinase-associated lipocalin in ng/mL
    measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure

    Full Information

    First Posted
    April 29, 2016
    Last Updated
    May 2, 2016
    Sponsor
    Clinical Hospital Centre Zagreb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02761577
    Brief Title
    A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia
    Official Title
    A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia With the Use of Standard Laboratory Measures and Novel Biomarkers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Clinical Hospital Centre Zagreb

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion. Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72 hours after the procedure
    Detailed Description
    Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion The first group of patients receives standard peroral hydration of 1500 ml water on the day of the procedure. The second group receives 3 mL/kg/hour of Na bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography. The third group receives parenteral NAC (1200 mg twice a day) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Na bicarbonate solution on the day of the angiography. The low-osmolar iodinated contrast agent was used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Diseases, Contrast Media Reaction
    Keywords
    Acetylcysteine, Sodium Bicarbonate, Lipocalins, Creatinine, Blood Urea Nitrogen

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    perorally 1500 ml water on the day of the procedure
    Arm Title
    Sodium bicarbonate
    Arm Type
    Experimental
    Arm Description
    3 mL/kg/hour IV (in vein) of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
    Arm Title
    N-acetylcysteine plus Sodium bicarbonate
    Arm Type
    Experimental
    Arm Description
    N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure in addition to Sodium bicarbonate solution on the day of the angiography.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium bicarbonate
    Other Intervention Name(s)
    NaHCO3
    Intervention Description
    3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
    Intervention Type
    Drug
    Intervention Name(s)
    N-acetylcysteine
    Other Intervention Name(s)
    fluimukan
    Intervention Description
    N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure
    Primary Outcome Measure Information:
    Title
    renal function before and after diagnostic procedure by measuring Serum creatinine in µmol/mL
    Description
    measure of serum creatinine before and after diagnostic procedure
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    blood urea nitrogen in mmol/L
    Description
    measure of blood urea nitrogen before and after diagnostic procedure
    Time Frame
    48 hours
    Title
    neutrophil gelatinase-associated lipocalin in ng/mL
    Description
    measure of neutrophil gelatinase-associated lipocalin before and after diagnostic procedure
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: angina (stable, unstable) coronary artery disease cardiomyopathy valvular disease vasculitis peripheral arterial disease Exclusion Criteria: kidney dysfunction uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg) pregnancy lactation history of allergic reaction to contrast agents cardiogenic shock pulmonary edema multiple myeloma urgent coronary angiography receiving contrast agents two days prior to the study and 48 hours within the study

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

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