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The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT

Primary Purpose

Septic Acute Kidney Injury

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluid management by the value of over hydration in Bioelectrical impedance
Fluid management by clinical-based ultrafiltration
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Acute Kidney Injury focused on measuring Septic AKI, CRRT, BIA

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. body temperature < 36 °C or > 38 °C
  2. heart rate > 90 BPM
  3. respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG
  4. White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10%
  5. Evidence of infection
  6. WBCs in normally sterile fluid
  7. Perforated viscus
  8. radiologically proven infection
  9. more than Injury stage in AKI according to RIFLE criteria
  10. septic AKI which is not explained by other cause
  11. patients signed a written informed consent.

Exclusion Criteria:

  1. Younger than 19 years old, older than 80 years old
  2. Previously undergoing dialysis treatment due to ESRD
  3. Underlying malignancy, Life expectancy shorter than 3 month
  4. AKI due to other than sepsis
  5. patients with intracardiac device such as Pacemaker, CRT, ICD

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

clinical-based ultrafiltration

BIA-based ultrafiltration

Arm Description

Outcomes

Primary Outcome Measures

28-day all cause mortality

Secondary Outcome Measures

Dialysis free rate

Full Information

First Posted
February 26, 2015
Last Updated
January 8, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02384525
Brief Title
The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute kidney injury(AKI) is one of the most common complications that occur up to 35% of critically ill patients. Septic AKI accounts for one third of them. Patients with septic AKI are widely treated with Continuous renal replacement therapy (CRRT). However, previous studies have hardly documented improvement of mortality in septic AKI patients. Otherwise, Fluid overload in septic shock patients who are undergoing CRRT is proven to be a significant predictor for mortality. Recent studies showed efficacy of bioelectrical impedance analysis and lung ultrasound in assessing fluid status of the patients. Thus, hypothesis of the study is that fluid assessment and control of fluid status using BIA and Lung Ultrasound could be related to the outcome of septic AKI patients who undergo CRRT. In this study, the investigators measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound for experimental group, while for control group, fluid status would be determined clinically by the physician. Ultrafiltration rate of experimental group is adjusted to be equal to the value of overhydration measured by BIA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Acute Kidney Injury
Keywords
Septic AKI, CRRT, BIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clinical-based ultrafiltration
Arm Type
Experimental
Arm Title
BIA-based ultrafiltration
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Fluid management by the value of over hydration in Bioelectrical impedance
Intervention Description
In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
Intervention Type
Procedure
Intervention Name(s)
Fluid management by clinical-based ultrafiltration
Intervention Description
In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
Primary Outcome Measure Information:
Title
28-day all cause mortality
Time Frame
28th day from CRRT
Secondary Outcome Measure Information:
Title
Dialysis free rate
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: body temperature < 36 °C or > 38 °C heart rate > 90 BPM respiratory rate > 20 or aPaCO2 < 32 mmHg on ABG White blood cell count < 4,000 cells/mm3 or > 12,000 cells/mm3 or band forms (immature white blood cells) ≥10% Evidence of infection WBCs in normally sterile fluid Perforated viscus radiologically proven infection more than Injury stage in AKI according to RIFLE criteria septic AKI which is not explained by other cause patients signed a written informed consent. Exclusion Criteria: Younger than 19 years old, older than 80 years old Previously undergoing dialysis treatment due to ESRD Underlying malignancy, Life expectancy shorter than 3 month AKI due to other than sepsis patients with intracardiac device such as Pacemaker, CRT, ICD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Hyun Yoo, MD
Phone
+82-2-2228-5345
Email
yoosy0316@yuhs.ac
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hyun Yoo, MD
Phone
82-2-2228-1989
Email
YOOSY0316@yuhs.ac

12. IPD Sharing Statement

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The Assessment of Volume Status by BIA and Lung Ultrasound in Septic AKI Patients Undergoing CRRT

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