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

NCT ID: NCT03916861

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intradialytic Hypotension Cardiac Event Renal Insufficiency Hospital Length of Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Bioelectrical Impedance Analysis

Intervention Type DEVICE

We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.

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.

Group Type ACTIVE_COMPARATOR

Physician-guided

Intervention Type PROCEDURE

This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day

Interventions

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Bioelectrical Impedance Analysis

We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.

Intervention Type DEVICE

Physician-guided

This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day

Intervention Type PROCEDURE

Other Intervention Names

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Fluid balance record

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangkok Metropolitan Administration Medical College and Vajira Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Thananda Trakarnvanich

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thananda Trakarnvanich

Role: PRINCIPAL_INVESTIGATOR

Vajira Hospital ,Navamindradhiraj University

Locations

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Thananda Trakarnvanich

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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106/60

Identifier Type: -

Identifier Source: org_study_id

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