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

M

Mahidol University

Status

Completed

Conditions

X-ray Contrast Media Adverse Reaction

Treatments

Other: standard hydration
Other: Bioimpedance guided

Study type

Interventional

Funder types

Other

Identifiers

NCT02449317
2558/171

Details and patient eligibility

About

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

Full description

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

Enrollment

56 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Control
Other group
Description:
standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
Treatment:
Other: standard hydration
Bioimpedance guided
Experimental group
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
Treatment:
Other: Bioimpedance guided

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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