Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

NCT ID: NCT05961631

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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

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Critically Ill

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive Fluid Balance 500ml or more

Fluid Balance measured using Bio-electrical Impedance Analysis

Bio-electrical Impedance Analysis

Intervention Type OTHER

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

Bio-electrical Impedance Analysis

Intervention Type OTHER

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

Interventions

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Bio-electrical Impedance Analysis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dita Aditianingsih

Principal investigator, MD, PhD, Anesthesiologist Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dita Aditianingsih, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 30072710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31474223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25432557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15380917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22165353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30394921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25593742 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26494153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33009098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19436332 (View on PubMed)

Other Identifiers

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IndonesiaUAnes045

Identifier Type: -

Identifier Source: org_study_id

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