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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.
The study, conducted at Thammasat University Hospital, aimed to assess the efficacy of different frequencies of BIA measurements in preventing intradialytic hypotension in ESRD patients undergoing hemodialysis.
The trial enrolled ESRD patients and collected data from June 2022 to February 2023.
Research Procedure:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| factors affecting intra-dialytic hypotension | The incidence rate ratio (numbers of intra-dialytic hypotension episodes/numbers of total hemodialytic episodes) will be calculated to explore whether individual parameters; for example, sex, age, underlying diseases, type of medication uses, data prior or during hemodialysis ( e.g. dialysis-vintage year, blood flow rate, interdialytic weight gain, etc.) or laboratory data relate to incidence rate ratio of intradialytic hypotension, or not. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aphichat Chatkrailert, M.D. | Thammasat University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25171342 | Result | 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. | |
| 19153263 | 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. |
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There was no plan to share IPD to other researchers. We used IPD in internal work only.
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| 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). |
| 21546884 | 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. |
| 31661683 | 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. |
| 33391741 | 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. |
| 33891656 | 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. |
| 15380917 | 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. |
| 34139470 | 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. |