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Critically IllNCT05961631

Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

An observational study of Critically Ill, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critically Ill
What is being tested?
Bio-electrical Impedance Analysis
How many people
200 participants
Where
1 siteIndonesia
Study dates
1 Sep 2023to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: all patients admitted to Intensive Care Unit Cipto Mangunkusumo Hospital and Indonesia University University

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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

Read the 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.

Conditions
Critically Ill
Being tested
Bio-electrical Impedance Analysis
Keywords
Bio-electrical Impedance Analysis, Fluid Accumulation
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bio-electrical Impedance AnalysisOther

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

Study groups in NCT05961631
Study groupRoleWhat they receive
Positive Fluid Balance 500ml or moreFluid Balance measured using Bio-electrical Impedance Analysis
Receives: Other: Bio-electrical Impedance Analysis
Fluid Balance 500ml or lessFluid Balance measured using Bio-electrical Impedance Analysis
Receives: Other: Bio-electrical Impedance Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid accumulation (FA)

    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%.

    Measured: 1 week

Secondary outcomes (4)

  1. volume excess (VE)

    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.

    Measured: 1 week

  2. total body weight (TBW)

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

    Measured: 1 week

  3. extracellular water (ECW)

    The amount of ECW (liters)

    Measured: 1 week

  4. intracellular water (ICW)

    The amount of ICW (liters)

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961631
Sponsor's protocol ID
IndonesiaUAnes045
Status last verified
May 2025
First submitted
18 Jul 2023
Last updated
2 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Finfer S, Myburgh J, Bellomo R. Intravenous fluid therapy in critically ill adults. Nat Rev Nephrol. 2018 Sep;14(9):541-557. doi: 10.1038/s41581-018-0044-0.

    PubMed 30072710

  • Sethakarun S, Bijaphala S, Kitiyakara C, Boongird S, Phanachet P, Reutrakul S, Pirojsakul K, Nongnuch A. Effect of bioelectrical impedance analysis-guided dry weight adjustment, in comparison to standard clinical-guided, on the sleep quality of chronic haemodialysis patients (BEDTIME study): a randomised controlled trial. BMC Nephrol. 2019 Sep 2;20(1):211. doi: 10.1186/s12882-019-1405-z.

    PubMed 31474223

  • Malbrain ML, Huygh J, Dabrowski W, De Waele JJ, Staelens A, Wauters J. The use of bio-electrical impedance analysis (BIA) to guide fluid management, resuscitation and deresuscitation in critically ill patients: a bench-to-bedside review. Anaesthesiol Intensive Ther. 2014 Nov-Dec;46(5):381-91. doi: 10.5603/AIT.2014.0061.

    PubMed 25432557

  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.

    PubMed 15380917

  • Sanchez M, Jimenez-Lendinez M, Cidoncha M, Asensio MJ, Herrerot E, Collado A, Santacruz M. Comparison of fluid compartments and fluid responsiveness in septic and non-septic patients. Anaesth Intensive Care. 2011 Nov;39(6):1022-9. doi: 10.1177/0310057X1103900607.

    PubMed 22165353

  • Lankadeva YR, Kosaka J, Iguchi N, Evans RG, Booth LC, Bellomo R, May CN. Effects of Fluid Bolus Therapy on Renal Perfusion, Oxygenation, and Function in Early Experimental Septic Kidney Injury. Crit Care Med. 2019 Jan;47(1):e36-e43. doi: 10.1097/CCM.0000000000003507.

    PubMed 30394921

  • Nunes TS, Ladeira RT, Bafi AT, de Azevedo LC, Machado FR, Freitas FG. Duration of hemodynamic effects of crystalloids in patients with circulatory shock after initial resuscitation. Ann Intensive Care. 2014 Aug 1;4:25. doi: 10.1186/s13613-014-0025-9. eCollection 2014.

    PubMed 25593742

  • Wang N, Jiang L, Zhu B, Wen Y, Xi XM; Beijing Acute Kidney Injury Trial (BAKIT) Workgroup. Fluid balance and mortality in critically ill patients with acute kidney injury: a multicenter prospective epidemiological study. Crit Care. 2015 Oct 23;19:371. doi: 10.1186/s13054-015-1085-4.

    PubMed 26494153

  • Messmer AS, Zingg C, Muller M, Gerber JL, Schefold JC, Pfortmueller CA. Fluid Overload and Mortality in Adult Critical Care Patients-A Systematic Review and Meta-Analysis of Observational Studies. Crit Care Med. 2020 Dec;48(12):1862-1870. doi: 10.1097/CCM.0000000000004617.

    PubMed 33009098

  • Bouchard J, Soroko SB, Chertow GM, Himmelfarb J, Ikizler TA, Paganini EP, Mehta RL; Program to Improve Care in Acute Renal Disease (PICARD) Study Group. Fluid accumulation, survival and recovery of kidney function in critically ill patients with acute kidney injury. Kidney Int. 2009 Aug;76(4):422-7. doi: 10.1038/ki.2009.159. Epub 2009 May 13.

    PubMed 19436332

Questions about this trial

What is this clinical trial studying?

An observational study of Critically Ill, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid accumulation (FA) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05961631, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.

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