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Clinical Trials/NCT02384525
NCT02384525UnknownNot Applicable

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

Yonsei University1 site in 1 country218 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
218
Locations
1
Primary Endpoint
28-day all cause mortality

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

clinical-based ultrafiltration

Experimental

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

BIA-based ultrafiltration

Active Comparator

Intervention: Fluid management by clinical-based ultrafiltration (Procedure)

Outcomes

Primary Outcomes

28-day all cause mortality

Time Frame: 28th day from CRRT

Secondary Outcomes

  • Dialysis free rate(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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