Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension

NCT06279156 | Completed

• 1 other identifier: MTU-EC-IM-0-014/65
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to compare the efficiencies of bioelectrical impedance analysis (BIA) measurement frequency in preventing intradialytic hypotension in end-stage renal disease (ESRD) patients undergoing regular hemodialysis. The main question aimed to answer about the optimum frequency of BIA measurements to prevent intradialytic hypotension. Participants underwent BIA measurements to determine their appropriate dry weight, and factors affecting intradialytic hypotension. Researchers compared the efficiencies of BIA measurements between the every-1-month group and the every-2-month group to prevent intradialytic hypotension.

Conditions

Intradialytic Hypotension; End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

• incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA

  Numbers of intra-dialytic hypotension sessions which each patient experiences when apply every-1-month BIA or every-2-month BIA will be collected. Then, the incidence rate of intra-dialytic hypotension (numbers of intra-dialytic hypotension episodes/numbers of total hemodialytic episodes) of every-1-month BIA or every-2-month BIA will be calculated. Finally, incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA will be calculated.

  In each 4-month period of each assigned intervention group during hemodialysis sessions (48 hemodialytic sessions of each patient in each group), or total observation time was 8 months (96 hemodialytic sessions of each patient in both groups).

Secondary Outcomes (1)

• factors affecting intra-dialytic hypotension

  In each 4-month period of each assigned intervention group (every-1-month BIA, and every-2-month BIA) during hemodialysis sessions (total observation time was 8 months).

Study Arms (2)

the first group (every-1-month BIA and then every-2-month BIA)

EXPERIMENTAL

measure Bioelectrical Impedance analysis (BIA) for patients' dry weight every 1 month for 4 months, and then every 2 months for 4 months

Device: Bioelectrical Impedance Analysis (BIA)

the second group (every-2-month BIA and then every-1-month BIA)

EXPERIMENTAL

measure Bioelectrical Impedance analysis (BIA) for patients' dry weight every 2 months for 4 months, and then every 1 month for 4 months

Device: Bioelectrical Impedance Analysis (BIA)

Interventions

Bioelectrical Impedance Analysis (BIA) DEVICE

Measure BIA for patients' dry weight to compare between measuring every-1-month or every-2-month. In brief, BIA is the machine used for measure body components such as fat, muscle, and free water. It relies on the principle of using the multifrequency of low electric currents to the body and measurement of the ability of the electrical currents passing different body composition. Thus, the machine can calculate back for the amount of each body composition.

the first group (every-1-month BIA and then every-2-month BIA); the second group (every-2-month BIA and then every-1-month BIA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• dialysis vintage ≥ 3 months
• hemodialysis at least thrice weekly
• hemodialysis ≥ 3 hours per session.

You may not qualify if:

• congestive heart failure (NYHA class 3-4)
• cardiac arrhythmias with relapse within 1 month and still unable to control symptoms during the drug adjustment period
• coronary artery disease which active within 1 month without treatment
• patients who take regular oral medications to raise blood pressure before undergoing dialysis such as midodrine
• patients with low blood pressure or requiring blood pressure medication adjustments within 1 month period
• has another unstable symptom

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Related Publications (8)

• Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23.

  PMID: 25171342 RESULT

• Agarwal R, Alborzi P, Satyan S, Light RP. Dry-weight reduction in hypertensive hemodialysis patients (DRIP): a randomized, controlled trial. Hypertension. 2009 Mar;53(3):500-7. doi: 10.1161/HYPERTENSIONAHA.108.125674. Epub 2009 Jan 19.

  PMID: 19153263 RESULT

• Breidthardt T, McIntyre CW. Dialysis-induced myocardial stunning: the other side of the cardiorenal syndrome. Rev Cardiovasc Med. 2011;12(1):13-20. doi: 10.3909/ricm0585.

  PMID: 21546884 RESULT

• Lee Y, Okuda Y, Sy J, Kim SR, Obi Y, Kovesdy CP, Rhee CM, Streja E, Kalantar-Zadeh K. Ultrafiltration Rate Effects Declines in Residual Kidney Function in Hemodialysis Patients. Am J Nephrol. 2019;50(6):481-488. doi: 10.1159/000503918. Epub 2019 Oct 29.

  PMID: 31661683 RESULT

• Kanbay M, Ertuglu LA, Afsar B, Ozdogan E, Siriopol D, Covic A, Basile C, Ortiz A. An update review of intradialytic hypotension: concept, risk factors, clinical implications and management. Clin Kidney J. 2020 Jul 8;13(6):981-993. doi: 10.1093/ckj/sfaa078. eCollection 2020 Dec.

  PMID: 33391741 RESULT

• Kim HR, Bae HJ, Jeon JW, Ham YR, Na KR, Lee KW, Hyon YK, Choi DE. A novel approach to dry weight adjustments for dialysis patients using machine learning. PLoS One. 2021 Apr 23;16(4):e0250467. doi: 10.1371/journal.pone.0250467. eCollection 2021.

  PMID: 33891656 RESULT

• 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.

  PMID: 15380917 RESULT

• Brunani A, Perna S, Soranna D, Rondanelli M, Zambon A, Bertoli S, Vinci C, Capodaglio P, Lukaski H, Cancello R. Body composition assessment using bioelectrical impedance analysis (BIA) in a wide cohort of patients affected with mild to severe obesity. Clin Nutr. 2021 Jun;40(6):3973-3981. doi: 10.1016/j.clnu.2021.04.033. Epub 2021 Apr 28.

  PMID: 34139470 RESULT

Study Officials

• Aphichat Chatkrailert, M.D.

  Thammasat University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thammasat University Hospital

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: June 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)