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

NCT02384525 | Unknown

• 1 other identifier: 4-2014-0791
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Acute Kidney Injury

Keywords

Septic AKI; CRRT; BIA

Outcome Measures

Primary Outcomes (1)

• 28-day all cause mortality

  28th day from CRRT

Secondary Outcomes (1)

• Dialysis free rate

  9 months

Study Arms (2)

clinical-based ultrafiltration

EXPERIMENTAL

Procedure: Fluid management by the value of over hydration in Bioelectrical impedance

BIA-based ultrafiltration

ACTIVE COMPARATOR

Procedure: Fluid management by clinical-based ultrafiltration

Interventions

Fluid management by the value of over hydration in Bioelectrical impedance PROCEDURE

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.

clinical-based ultrafiltration

Fluid management by clinical-based ultrafiltration PROCEDURE

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.

BIA-based ultrafiltration

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Interventions

Electric Impedance

Intervention Hierarchy (Ancestors)

Electric Conductivity; Electricity; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena

Central Study Contacts

Tae Hyun Yoo, MD

CONTACT

+82-2-2228-5345; yoosy0316@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 10, 2015
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

KR (1)