Clinical trial NCT05961631: Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Bio-electrical Impedance Analysis
Fluid Accumulation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients admitted to Intensive Care Unit Cipto Mangunkusumo Hospital and Indonesia University 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fluid accumulation (FA)
timeFrame: 1 week
Secondary outcomes:
measure: volume excess (VE)
timeFrame: 1 week
measure: total body weight (TBW)
timeFrame: 1 week
measure: extracellular water (ECW)
timeFrame: 1 week
measure: intracellular water (ICW)
timeFrame: 1 week
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Erratum In: Nat Rev Nephrol. 2018 Nov;14(11):717. doi: 10.1038/s41581-018-0060-0.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.