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

Study Overview
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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.

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

Conditions
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Cardiac Event, Intradialytic Hypotension, Renal Insufficiency, Hospital Length of Stay

Intervention / Treatment
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* Device: Bioelectrical Impedance Analysis
* Procedure: Physician-guided


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioelectrical Impedance<br>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<br>* We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.<br>|
| Active Comparator: Physicain-guided group<br>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<br>* This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day<br>* Other names: Fluid balance record;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac problem | 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 | Total days in admission | Up to 3 months after enrollment | 
| Percent of renal function | eGFR | at least 3 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, BIA, Acute Kidney Injury