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

NCT03916861 | Completed DMC

• 1 other identifier: 106/60
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intradialytic Hypotension; Cardiac Event; Renal Insufficiency; Hospital Length of Stay

Keywords

Hemodialysis; BIA; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure during dialysis

  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 Outcomes (3)

• Cardiac problem

  Measure through study completion,for at least 3 months after randomization

• Hospital length of stay

  Up to 3 months after enrollment

• Percent of renal function

  at least 3 months after enrollment

Study Arms (2)

Bioelectrical Impedance

EXPERIMENTAL

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.

Device: Bioelectrical Impedance Analysis

Physicain-guided group

ACTIVE COMPARATOR

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.

Procedure: Physician-guided

Interventions

Bioelectrical Impedance Analysis DEVICE

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

Bioelectrical Impedance

Physician-guided PROCEDURE

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

Also known as: Fluid balance record

Physicain-guided group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: More than 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Thananda Trakarnvanich

Bangkok, Bangkok, 10170, Thailand

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Thananda Trakarnvanich

  Vajira Hospital ,Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective randomized study

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 16, 2019
• Study Start: October 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)