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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916861
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital

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.

Condition or disease Intervention/treatment Phase
Intradialytic Hypotension Cardiac Event Renal Insufficiency Hospital Length of Stay Device: Bioelectrical Impedance Analysis Procedure: Physician-guided Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


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.
Device: Bioelectrical Impedance Analysis
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.
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
Other Name: Fluid balance record




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Hospital length of stay [ Time Frame: Up to 3 months after enrollment ]
    Total days in admission

  3. Percent of renal function [ Time Frame: at least 3 months after enrollment ]
    eGFR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   More than 18 years old
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916861


Locations
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Thailand
Thananda Trakarnvanich
Bangkok, กรุงเทพมหานคร, Thailand, 10170
Sponsors and Collaborators
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Investigators
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Principal Investigator: Thananda Trakarnvanich Vajira Hospital ,Navamindradhiraj University
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Responsible Party: Thananda Trakarnvanich, Associate Professor, Bangkok Metropolitan Administration Medical College and Vajira Hospital
ClinicalTrials.gov Identifier: NCT03916861    
Other Study ID Numbers: 106/60
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital:
Hemodialysis
BIA
Acute Kidney Injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Hypotension
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases