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

Not Applicable

Completed

• Conditions: X-ray Contrast Media Adverse Reaction
• Interventions: Other: Bioimpedance guided; Other: standard hydration

• Registration Number: NCT02449317
• Lead Sponsor: Mahidol University

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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-20
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
serum creatinine at 48-72 hours after contrast administration	48-72 hr	Acute kidney injury

Secondary Outcome Measures

Name	Time	Method
serum creatinine at 2 weeks after contrast administration	2 weeks	Renal replacement therapy