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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03916861
Other study ID # 106/60
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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