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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Acute Kidney Injury
• Intervention / Treatment: Procedure: Fluid management by the value of over hydration in Bioelectrical impedance; Procedure: Fluid management by clinical-based ultrafiltration

• Study Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Tae Hyun Yoo, MD; Phone Number: 82-2-2228-1989; Email: YOOSY0316@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clinical-based ultrafiltration	Procedure: Fluid management by the value of over hydration in Bioelectrical impedance; 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.
Active Comparator: BIA-based ultrafiltration	Procedure: Fluid management by clinical-based ultrafiltration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day all cause mortality	28th day from CRRT

Secondary Outcome Measures

Outcome Measure	Time Frame
Dialysis free rate	9 months

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 10, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: CRRT; BIA; Septic AKI
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 4-2014-0791