Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

Completed

• Conditions: Critically Ill
• Interventions: Other: Bio-electrical Impedance Analysis

• Registration Number: NCT05961631
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluid Balance 500ml or less	Bio-electrical Impedance Analysis	Fluid Balance measured using Bio-electrical Impedance Analysis
Positive Fluid Balance 500ml or more	Bio-electrical Impedance Analysis	Fluid Balance measured using Bio-electrical Impedance Analysis

Primary Outcome Measures

Name	Time	Method
Fluid accumulation (FA)	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 Outcome Measures

Name	Time	Method
volume excess (VE)	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.
total body weight (TBW)	1 week	The total mass or weight quantity of a person is obtained from BIA (Bioelectrical Impedance Analysis) measurements.
extracellular water (ECW)	1 week	The amount of ECW (liters)
intracellular water (ICW)	1 week	The amount of ICW (liters)

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia