- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916861
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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
กรุงเทพมหานคร
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Bangkok, กรุงเทพมหานคร, Thailand, 10170
- Thananda Trakarnvanich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
|
ACTIVE_COMPARATOR: 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.
|
This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure during dialysis
Time Frame: During hemodialysis session start from enrollment until study completion, up to 4 hours
|
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
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During hemodialysis session start from enrollment until study completion, up to 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac problem
Time Frame: Measure through study completion,for at least 3 months after randomization
|
Number of patients that have palpitation,cardiac arrthymia or chest pain
|
Measure through study completion,for at least 3 months after randomization
|
Hospital length of stay
Time Frame: Up to 3 months after enrollment
|
Total days in admission
|
Up to 3 months after enrollment
|
Percent of renal function
Time Frame: at least 3 months after enrollment
|
eGFR
|
at least 3 months after enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thananda Trakarnvanich, Vajira Hospital ,Navamindradhiraj University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 106/60
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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