Clinical trial NCT03916861: BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
Official title: Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intradialytic Hypotension
Cardiac Event
Renal Insufficiency
Hospital Length of Stay
Keywords: Hemodialysis
BIA
Acute Kidney Injury
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized study
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure during dialysis
timeFrame: During hemodialysis session start from enrollment until study completion, up to 4 hours
Secondary outcomes:
measure: Cardiac problem
timeFrame: Measure through study completion,for at least 3 months after randomization
measure: Hospital length of stay
timeFrame: Up to 3 months after enrollment
measure: Percent of renal function
timeFrame: at least 3 months after enrollment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Thananda Trakarnvanich
state: กรุงเทพมหานคร
Study officials:
affiliation: Vajira Hospital ,Navamindradhiraj University
name: Thananda Trakarnvanich
role: PRINCIPAL_INVESTIGATOR
References: