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

Bioimpedance Analysis Guided Volume Expansion for the Prevention of Contrast

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

Study Overview

• Status: Completed
• Conditions: X-ray Contrast Media Adverse Reaction
• Intervention / Treatment: Other: standard hydration; Other: Bioimpedance guided

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; standard hydration : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours	Other: standard hydration; standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum creatinine at 48-72 hours after contrast administration	Acute kidney injury	48-72 hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum creatinine at 2 weeks after contrast administration	Renal replacement therapy	2 weeks

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 17, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: contrast induced acute kidney injury; bioimpedance
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 2558/171