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

Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02449317
Acronym
BELIEVE
Enrollment
56
Registered
2015-05-20
Start date
2015-05-31
Completion date
2016-01-31
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

X-ray Contrast Media Adverse Reaction

Keywords

contrast induced acute kidney injury, bioimpedance

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

Interventions

OTHERBioimpedance guided

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
serum creatinine at 48-72 hours after contrast administration48-72 hrAcute kidney injury

Secondary

MeasureTime frameDescription
serum creatinine at 2 weeks after contrast administration2 weeksRenal replacement therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026