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

NCT02449317 | Completed DMC

• 1 other identifier: 2558/171
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

X-ray Contrast Media Adverse Reaction

Keywords

contrast induced acute kidney injury; bioimpedance

Outcome Measures

Primary Outcomes (1)

• serum creatinine at 48-72 hours after contrast administration

  Acute kidney injury

  48-72 hr

Secondary Outcomes (1)

• serum creatinine at 2 weeks after contrast administration

  2 weeks

Study Arms (2)

Control

OTHER

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

Bioimpedance guided

EXPERIMENTAL

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

Interventions

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

Bioimpedance guided

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

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Officials

• Arkom Nongnuch, MD

  Ramathibodi hospital, Mahidol university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: May 20, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 1, 2017

Record last verified: 2017-08