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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02384525
Enrollment
218
Registered
2015-03-10
Start date
2017-01-01
Completion date
2019-11-30
Last updated
2019-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Acute Kidney Injury

Keywords

Septic AKI, CRRT, BIA

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.

Interventions

PROCEDUREFluid 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.

PROCEDUREFluid 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
28-day all cause mortality28th day from CRRT

Secondary

MeasureTime frame
Dialysis free rate9 months

Countries

South Korea

Contacts

Primary ContactTae Hyun Yoo, MD
yoosy0316@yuhs.ac+82-2-2228-5345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026