Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

Sponsor
Indonesia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05961631
Collaborator
(none)
202
18

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Bio-electrical Impedance Analysis

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 Design

Study Type:
Observational
Anticipated Enrollment :
202 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Use of Bio-Electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation in Critically Ill Patients Admitted to ICU: a Cohort Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Positive Fluid Balance 500ml or more

Fluid Balance measured using Bio-electrical Impedance Analysis

Other: Bio-electrical Impedance Analysis
Variable measured: Fluid accumulation (FA), volume excess (VE), total body weight (TBW), extracellular water (ECW), intracellular water (ICW)

Fluid Balance 500ml or less

Fluid Balance measured using Bio-electrical Impedance Analysis

Other: Bio-electrical Impedance Analysis
Variable measured: Fluid accumulation (FA), volume excess (VE), total body weight (TBW), extracellular water (ECW), intracellular water (ICW)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. total body weight (TBW) [1 week]

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

  3. extracellular water (ECW) [1 week]

    The amount of ECW (liters)

  4. intracellular water (ICW) [1 week]

    The amount of ICW (liters)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Dita Aditianingsih, M.D, Ph.D, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dita Aditianingsih, Principal investigator, MD, PhD, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier:
NCT05961631
Other Study ID Numbers:
  • IndonesiaUAnes045
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dita Aditianingsih, Principal investigator, MD, PhD, Anesthesiologist Consultant, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2023