End Stage Renal Disease on Dialysis Clinical Trial
Official title:
Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension
Verified date | March 2024 |
Source | Thammasat University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - over 18 years of age - dialysis vintage = 3 months - hemodialysis at least thrice weekly - hemodialysis = 3 hours per session. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Thammasat University Hospital | Pathum Thani |
Lead Sponsor | Collaborator |
---|---|
Thammasat University Hospital |
Thailand,
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. — View Citation
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. — View Citation
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. Cli — View Citation
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 — View Citation
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. — 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 principl — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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). |
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