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

Not Applicable

Completed

• Conditions: Intradialytic Hypotension; Cardiac Event; Renal Insufficiency; Hospital Length of Stay
• Interventions: Procedure: Physician-guided; Device: Bioelectrical Impedance Analysis

• Registration Number: NCT03916861
• Lead Sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

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 Timeline

• Study Start: 2017-10-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2019-04
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physicain-guided group	Physician-guided	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.
Bioelectrical Impedance	Bioelectrical Impedance Analysis	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thananda Trakarnvanich; 🇹🇭 Bangkok, กรุงเทพมหานคร, Thailand