Bio-electrical Impedance Analysis Derived Parameters for Evaluating Fluid Accumulation

Critically Ill Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05961631
• Other study ID #: IndonesiaUAnes045
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2023
• Source: Indonesia University
• Contact: Dita Aditianingsih, M.D, Ph.D
• Phone: +618151819244
• Email: ditaaditiaa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	1 week
Secondary	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.	1 week
Secondary	total body weight (TBW)	The total mass or weight quantity of a person is obtained from BIA (Bioelectrical Impedance Analysis) measurements.	1 week
Secondary	extracellular water (ECW)	The amount of ECW (liters)	1 week
Secondary	intracellular water (ICW)	The amount of ICW (liters)	1 week