An interventional study of Bioelectrical Impedance Analysis and Physician-guided in Intradialytic Hypotension, Cardiac Event and Renal Insufficiency, sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Bangkok Metropolitan Administration Medical College and Vajira Hospital · Not applicable, Interventional, and Prevention
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.
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's enrollment of 9 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Bangkok Metropolitan Administration Medical College and Vajira Hospital is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients who were pregnant
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
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
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
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
Change in blood pressure during dialysis
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
Time frame: During hemodialysis session start from enrollment until study completion, up to 4 hours
Cardiac problem
Number of patients that have palpitation,cardiac arrthymia or chest pain
Time frame: Measure through study completion,for at least 3 months after randomization
Hospital length of stay
Total days in admission
Time frame: Up to 3 months after enrollment
Percent of renal function
eGFR
Time frame: at least 3 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Feb 2018, 4 months.
Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 4 months is below that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Bangkok Metropolitan Administration Medical College and Vajira Hospital