Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in blood pressure during dialysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute kidney injury with volume overload unresponsive to medication therapy =Required renal replacement therapy (RRT)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Bioelectrical Impedance Analysis (Device)
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.
干预措施: Physician-guided (Procedure)
结局指标
主要结局
Change in blood pressure during dialysis
时间窗: During hemodialysis session start from enrollment until study completion, up to 4 hours
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
次要结局
- Hospital length of stay(Up to 3 months after enrollment)
- Percent of renal function(at least 3 months after enrollment)
- Cardiac problem(Measure through study completion,for at least 3 months after randomization)
研究者
Thananda Trakarnvanich
Associate Professor
Bangkok Metropolitan Administration Medical College and Vajira Hospital