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Completed

NCT Number: NCT05961631

Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

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

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bio-electrical Impedance Analysis

Other

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

Primary outcomes

  1. Fluid accumulation (FA)

    Time frame: 1 week

    Each 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 outcomes

  1. volume excess (VE)

    Time frame: 1 week

    Fluid 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.

  2. total body weight (TBW)

    Time frame: 1 week

    The total mass or weight quantity of a person is obtained from BIA (Bioelectrical Impedance Analysis) measurements.

  3. extracellular water (ECW)

    Time frame: 1 week

    The amount of ECW (liters)

  4. intracellular water (ICW)

    Time frame: 1 week

    The amount of ICW (liters)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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