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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916861
• Other study ID #: 106/60
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: April 2019
• Source: Bangkok Metropolitan Administration Medical College and Vajira Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Event
• Hospital Length of Stay
• Hypotension
• Intradialytic Hypotension
• Renal Insufficiency

Intervention

Device:
• Bioelectrical Impedance Analysis
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.

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

Locations

Country	Name	City	State
Thailand	Thananda Trakarnvanich	Bangkok	?????????????

Sponsors (1)

Lead Sponsor	Collaborator
Bangkok Metropolitan Administration Medical College and Vajira Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure during dialysis	Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)	During hemodialysis session start from enrollment until study completion, up to 4 hours
Secondary	Cardiac problem	Number of patients that have palpitation,cardiac arrthymia or chest pain	Measure through study completion,for at least 3 months after randomization
Secondary	Hospital length of stay	Total days in admission	Up to 3 months after enrollment
Secondary	Percent of renal function	eGFR	at least 3 months after enrollment