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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

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • 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
  • Hospital length of stay [ Time Frame: Up to 3 months after enrollment ]
    Total days in admission
  • Percent of renal function [ Time Frame: at least 3 months after enrollment ]
    eGFR
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BIA Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy
Official Title  ICMJE Bioelectrical Impedance Analysis Versus Physician Adjustment in Acute Kidney Injury Patients Requiring Renal Replacement Therapy;Which One Can Help Reduce Intradialytic Hypotension
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective randomized study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Intradialytic Hypotension
  • Cardiac Event
  • Renal Insufficiency
  • Hospital Length of Stay
Intervention  ICMJE
  • 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
    Other Name: Fluid balance record
Study Arms  ICMJE
  • 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.
    Intervention: Device: Bioelectrical Impedance Analysis
  • 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.
    Intervention: Procedure: Physician-guided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: More than 18 years old
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916861
Other Study ID Numbers  ICMJE 106/60
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thananda Trakarnvanich, Bangkok Metropolitan Administration Medical College and Vajira Hospital
Study Sponsor  ICMJE Bangkok Metropolitan Administration Medical College and Vajira Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thananda Trakarnvanich Vajira Hospital ,Navamindradhiraj University
PRS Account Bangkok Metropolitan Administration Medical College and Vajira Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP