BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
Primary Purpose
Intradialytic Hypotension, Cardiac Event, Renal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Bioelectrical Impedance Analysis
Physician-guided
Sponsored by
About this trial
This is an interventional prevention trial for Intradialytic Hypotension focused on measuring Hemodialysis, BIA, Acute Kidney Injury
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
Sites / Locations
- Thananda Trakarnvanich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bioelectrical Impedance
Physicain-guided group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in blood pressure during dialysis
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
Secondary Outcome Measures
Cardiac problem
Number of patients that have palpitation,cardiac arrthymia or chest pain
Hospital length of stay
Total days in admission
Percent of renal function
eGFR
Full Information
NCT ID
NCT03916861
First Posted
April 1, 2019
Last Updated
April 15, 2019
Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03916861
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangkok Metropolitan Administration Medical College and Vajira Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension, Cardiac Event, Renal Insufficiency, Hospital Length of Stay
Keywords
Hemodialysis, BIA, Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bioelectrical Impedance
Arm Type
Experimental
Arm Description
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.
Arm Title
Physicain-guided group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bioelectrical Impedance Analysis
Intervention Description
We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
Intervention Type
Procedure
Intervention Name(s)
Physician-guided
Other Intervention Name(s)
Fluid balance record
Intervention Description
This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day
Primary Outcome Measure Information:
Title
Change in blood pressure during dialysis
Description
Blood pressure less than 20 mmHg from baseline ( systolic blood pressure)
Time Frame
During hemodialysis session start from enrollment until study completion, up to 4 hours
Secondary Outcome Measure Information:
Title
Cardiac problem
Description
Number of patients that have palpitation,cardiac arrthymia or chest pain
Time Frame
Measure through study completion,for at least 3 months after randomization
Title
Hospital length of stay
Description
Total days in admission
Time Frame
Up to 3 months after enrollment
Title
Percent of renal function
Description
eGFR
Time Frame
at least 3 months after enrollment
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
More than 18 years old
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thananda Trakarnvanich
Organizational Affiliation
Vajira Hospital ,Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thananda Trakarnvanich
City
Bangkok
State/Province
กรุงเทพมหานคร
ZIP/Postal Code
10170
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
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