BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy

April 15, 2019 updated by: Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension

This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy. The investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.

Study Overview

Detailed Description

Background

Volume overload and intradialytic hypotension are significant complications with increasing mortality rate in hemodialysis patients. Bioelectrical Impedance Analysis (BIA) has been used to estimate the optimum weight in chronic hemodialysis patient to prevent intradialytic hypotension.Volume assessment in acute kidney injury is also of great importance , however, there are currently few methods to obtain an accurate assessment of hydration status in this scenario. This study was designed to compare the efficacy of BIA and physician adjustment to prevent intradialytic hypotension in patients with acute kidney injury who received renal replacement therapy.

Methods

The investigators randomized 9 patients with acute kidney injury and volume overloaded who underwent acute hemodialysis for 45 sessions in Vajira hospital between October 2017 and February 2018. Volume overload was defined by BIA with value more than>0.4. In physician adjust-group (control) estimate by physical examination and fluid balance record. Primary outcome was intradialytic hypotensive episode and secondary outcome was hemodialysis-related adverse events and other clinical outcome.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • กรุงเทพมหานคร
      • Bangkok, กรุงเทพมหานคร, Thailand, 10170
        • Thananda Trakarnvanich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with acute kidney injury with volume overload unresponsive to medication therapy =Required renal replacement therapy (RRT)

Exclusion Criteria:

Patients who were pregnant

  • Advanced malignancy
  • Kidney transplantation
  • AKI from toxins
  • Currently on pacemaker
  • Had underlying chronic kidney disease
  • Patients with severe cardiovascular disease such as congestive heart failure, valvular regurgition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bioelectrical Impedance
The first group will be monitored by Inbody S20 analysis to measure fluid status. The Bioimpedance will be measured each time prior to hemodialysis session . The value of BIA measurement of more than 0.4 will be considered as edema.
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
ACTIVE_COMPARATOR: Physicain-guided group
The fluid monitoring will be managed by physician-adjustment by physical examination and fluid balance record . The fluid balance (FB) is the total fluid administered minus the total fluids eliminated over a period of time.
This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day
Other Names:
  • Fluid balance record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure during dialysis
Time Frame: During hemodialysis session start from enrollment until study completion, up to 4 hours
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
During hemodialysis session start from enrollment until study completion, up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac problem
Time Frame: Measure through study completion,for at least 3 months after randomization
Number of patients that have palpitation,cardiac arrthymia or chest pain
Measure through study completion,for at least 3 months after randomization
Hospital length of stay
Time Frame: Up to 3 months after enrollment
Total days in admission
Up to 3 months after enrollment
Percent of renal function
Time Frame: at least 3 months after enrollment
eGFR
at least 3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thananda Trakarnvanich, Vajira Hospital ,Navamindradhiraj University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

February 28, 2018

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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