BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
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|ClinicalTrials.gov Identifier: NCT03916861|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intradialytic Hypotension Cardiac Event Renal Insufficiency Hospital Length of Stay||Device: Bioelectrical Impedance Analysis Procedure: Physician-guided||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized study|
|Masking:||None (Open Label)|
|Official Title:||Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
Experimental: 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.
Device: Bioelectrical Impedance Analysis
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
Active Comparator: 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.
This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day
Other Name: Fluid balance record
- 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)
- 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
- Hospital length of stay [ Time Frame: Up to 3 months after enrollment ]Total days in admission
- Percent of renal function [ Time Frame: at least 3 months after enrollment ]eGFR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916861
|Bangkok, กรุงเทพมหานคร, Thailand, 10170|
|Principal Investigator:||Thananda Trakarnvanich||Vajira Hospital ,Navamindradhiraj University|