Skip to main content
OpenTrials
Completed

NCT Number: NCT02449317

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

Bioelectrical impedance analysis guided volume expansion for the prevention of contrast induced-acute kidney injury

Completed

Looking for future studies?

Notify Me

Key information

Conditions

X-ray Contrast Media Adverse Reaction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Compared bioelectrical impedance analysis guided hydration therapy versus standard hydration for the prevention of contrast induced-acute kidney injury

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioimpedance guided

Other

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

Standard Hydration

Other

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

Primary outcomes

  1. serum creatinine at 48-72 hours after contrast administration

    Time frame: 48-72 hr

    Acute kidney injury

Secondary outcomes

  1. serum creatinine at 2 weeks after contrast administration

    Time frame: 2 weeks

    Renal replacement therapy

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast

Acronym: BELIEVE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 20, 2015
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.