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Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury (BELIEVE)

Primary Purpose

X-ray Contrast Media Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bioimpedance guided
standard hydration
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for X-ray Contrast Media Adverse Reaction focused on measuring contrast induced acute kidney injury, bioimpedance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-90 yr
  2. Chronic kidney disease stage 3 & 4 (eGFR 15-60 ml/min/m2)
  3. elective cardiac catheterization

Exclusion Criteria:

  1. Contrast media administration in the past 14 days
  2. congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease
  3. Kidney transplant status or RRT
  4. Emergency cardiac catheterization
  5. Allergy to radiographic contrast media
  6. Unstable renal function (change in serum creatinine ≥ 0.5 mg/dl or 25% within 14 days prior to the study
  7. Not inform consent
  8. left ventricular ejection fraction < 40 %
  9. Liver cirrhosis child B or C
  10. Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Control

    Bioimpedance guided

    Arm Description

    standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours

    Bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water extracellular water/total body water < 0.36 : 4 ml/kg/hr extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr extracellular water/total body water > 0.4 : 1 ml/kg/hr

    Outcomes

    Primary Outcome Measures

    serum creatinine at 48-72 hours after contrast administration
    Acute kidney injury

    Secondary Outcome Measures

    serum creatinine at 2 weeks after contrast administration
    Renal replacement therapy

    Full Information

    First Posted
    May 17, 2015
    Last Updated
    August 31, 2017
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02449317
    Brief Title
    Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury
    Acronym
    BELIEVE
    Official Title
    Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury
    Detailed Description
    Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    X-ray Contrast Media Adverse Reaction
    Keywords
    contrast induced acute kidney injury, bioimpedance

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
    Arm Title
    Bioimpedance guided
    Arm Type
    Experimental
    Arm Description
    Bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water extracellular water/total body water < 0.36 : 4 ml/kg/hr extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr extracellular water/total body water > 0.4 : 1 ml/kg/hr
    Intervention Type
    Other
    Intervention Name(s)
    Bioimpedance guided
    Intervention Description
    bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water extracellular water/total body water < 0.36 : 4 ml/kg/hr extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr extracellular water/total body water > 0.4 : 1 ml/kg/hr
    Intervention Type
    Other
    Intervention Name(s)
    standard hydration
    Intervention Description
    standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
    Primary Outcome Measure Information:
    Title
    serum creatinine at 48-72 hours after contrast administration
    Description
    Acute kidney injury
    Time Frame
    48-72 hr
    Secondary Outcome Measure Information:
    Title
    serum creatinine at 2 weeks after contrast administration
    Description
    Renal replacement therapy
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-90 yr Chronic kidney disease stage 3 & 4 (eGFR 15-60 ml/min/m2) elective cardiac catheterization Exclusion Criteria: Contrast media administration in the past 14 days congestive heart failure (NYHA III-IV, ascites , pleuropericardial effusion ,severe valvular heart disease Kidney transplant status or RRT Emergency cardiac catheterization Allergy to radiographic contrast media Unstable renal function (change in serum creatinine ≥ 0.5 mg/dl or 25% within 14 days prior to the study Not inform consent left ventricular ejection fraction < 40 % Liver cirrhosis child B or C Dosage of angiotensin-converting enzyme inhibitor /angiotensin II receptor blocker changed in past 2 wk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arkom Nongnuch, MD
    Organizational Affiliation
    Ramathibodi hospital, Mahidol university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast Induced-acute Kidney Injury

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