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Completed

NCT Number: NCT03916861

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

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.

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Key information

Conditions

Intradialytic Hypotension Acute Kidney Injury Cardiac Event Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hospital Length of Stay Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thananda Trakarnvanich

Bangkok, 10170, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioelectrical Impedance Analysis

Device

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

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

Other names: Fluid balance record

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Hospital length of stay

    Time frame: Up to 3 months after enrollment

    Total days in admission

  3. Percent of renal function

    Time frame: at least 3 months after enrollment

    eGFR

Sponsors and collaborators

Lead sponsor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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