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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03916861
Enrollment
9
Registered
2019-04-16
Start date
2017-10-01
Completion date
2018-02-28
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hemodialysis, BIA, Acute Kidney Injury

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.

Interventions

We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.

PROCEDUREPhysician-guided

This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day

Sponsors

Bangkok Metropolitan Administration Medical College and Vajira Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective randomized study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure during dialysisDuring hemodialysis session start from enrollment until study completion, up to 4 hoursBlood pressure less than 20 mmHg from baseline ( systolic blood pressure)

Secondary

MeasureTime frameDescription
Cardiac problemMeasure through study completion,for at least 3 months after randomizationNumber of patients that have palpitation,cardiac arrthymia or chest pain
Hospital length of stayUp to 3 months after enrollmentTotal days in admission
Percent of renal functionat least 3 months after enrollmenteGFR

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026