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Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

The Use of Bio-Electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation in Critically Ill Patients Admitted to ICU: a Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05961631
Enrollment
200
Registered
2023-07-27
Start date
2023-09-01
Completion date
2025-03-31
Last updated
2025-05-02

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

Conditions

Critically Ill

Keywords

Bio-electrical Impedance Analysis, Fluid Accumulation

Brief summary

The purpose of this study is to assess fluid accumulation (FA) in the body using BIA (Bioelectrical Impedance Analysis) in critically ill patients treated in the ICU. This study is an observational cohort with an initial phase that analyzes prospective individual patient data

Detailed description

This research will begin by identifying subjects through the collection of initial data. The identification of subjects will involve using BIA (Bioelectrical Impedance Analysis) equipment. Subsequently, the subjects will be divided into two groups based on the initial BIA test results of body fluid balance. The first group will comprise patients with a body fluid balance exceeding 500cc, while the second group will consist of patients with a body fluid balance of 500cc or less. Throughout the study, various BIA-derived parameters will be closely monitored for both groups, starting from the initial BIA test until the patients are discharged from the ICU or for a maximum of 7 days of ICU care from the time of the first test.

Interventions

Variable measured: Fluid accumulation (FA), volume excess (VE), total body weight (TBW), extracellular water (ECW), intracellular water (ICW)

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* New patients admitted to Intensive Care Unit Cipto Mangunkusumo Hospital and Indonesia University University * Willing to be included in this research and signed the consent form

Exclusion criteria

* Obesity(BMI\>35kg/m²) OR underweight (BMI \< 18,5 kg/m²) * Pregnant or Breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Fluid accumulation (FA)1 weekEach increase in volume excess is divided by the patient's initial body weight and expressed as a percentage. FA (fluid accumulation) is considered positive if the percentage value is greater than 5%. Conversely, FA is considered negative if the percentage value is less than 5%.

Secondary

MeasureTime frameDescription
volume excess (VE)1 weekFluid volume expansion outside the cells, based on the assessment by BIA (Bioelectrical Impedance Analysis), refers to the increase in fluid volume that occurs outside the cells of the body.
total body weight (TBW)1 weekThe total mass or weight quantity of a person is obtained from BIA (Bioelectrical Impedance Analysis) measurements.
extracellular water (ECW)1 weekThe amount of ECW (liters)
intracellular water (ICW)1 weekThe amount of ICW (liters)

Countries

Indonesia

Outcome results

None listed

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