Intradialytic HypotensionNCT06279156
Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension
A study testing Bioelectrical Impedance Analysis (BIA) in people with Intradialytic Hypotension and End Stage Renal Disease on Dialysis, run by Thammasat University Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, End Stage Renal Disease on Dialysis
- What is being tested?
- Bioelectrical Impedance Analysis (BIA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- dialysis vintage ≥ 3 months
- hemodialysis at least thrice weekly
- hemodialysis ≥ 3 hours per session.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- Screening for eligibility was conducted among individuals undergoing hemodialysis at the hemodialysis unit of Thammasat University Hospital.
- Informed consent was obtained from participants or their authorized representatives.
- Basic demographic and medical data were recorded, including gender, age, pre-existing conditions, causes of kidney disease, smoking habits, regular medications. The dry weight, interdialytic weight gain (IDWG), and net ultrafiltration (UF) were calculated from every session of the patient's dialysis, and then taken the average. Blood flow rate (BFR) and dialysate temperature were taken from the largest value from each dialysis session and the greatest frequency. Single pool KT/V and blood tests (hemoglobin, serum albumin, electrolytes) were from the closest value before entering the research. Pre-dialysis systolic blood pressure (SBP) and diastolic blood pressure (DBP) were the average values.
- Volunteers were randomly assigned to two groups, each consisting of 45 individuals. Group 1 underwent BIA measurements monthly for 4 months, then switched to bi-monthly BIA measurements for 4 months. Group 2 underwent BIA measurements every 2 months for 4 months, then switched to monthly BIA measurements for 4 months. Data were used as a combination to adjust dry weight for accurate fluid removal.
- Episodes of intra-dialyltic hypotension were recorded and the numbers of such episodes were calculated as incidence rates to explore the most optimum frequency of BIA measurement (between every-1-month group and the every-2-month). Intradialytic hypotension in this study was defined as a decrease in (SBP) ≥ 20 mmHg or a decrease in mean arterial pressure (MAP) ≥ 10 mmHg. For BIA measurements in addition to the presence of intradialytic hypotension, the number of occurrences of intradialytic hypotension was counted as one increase.
- Factors affecting intradialytic hypotension were also explored.
- Being tested
- Bioelectrical Impedance Analysis (BIA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Bioelectrical Impedance Analysis (BIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jun 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aphichat Chatkrailert, Thammasat University Hospital
- Investigators
- Aphichat Chatkrailert, M.D., Principal investigator, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279156
- Sponsor's protocol ID
- MTU-EC-IM-0-014/65
- Status last verified
- Mar 2024
- First submitted
- 18 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There was no plan to share IPD to other researchers. We used IPD in internal work only.
Publications
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.
PubMed 25171342Agarwal 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.
PubMed 19153263Breidthardt 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.
PubMed 21546884Lee 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.
PubMed 31661683Kanbay 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.
PubMed 33391741Kim 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.
PubMed 33891656Kyle 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.
PubMed 15380917Brunani 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.
PubMed 34139470
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension
- ClinicalTrials.gov ID
- NCT06279156
- Acronym / sponsor ID
- MTU-EC-IM-0-014/65
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Screening for eligibility was conducted among individuals undergoing hemodialysis at the hemodialysis unit of Thammasat University Hospital.
- Informed consent was obtained from participants or their authorized representatives.
- Basic demographic and medical data were recorded, including gender, age, pre-existing conditions, causes of kidney disease, smoking habits, regular medications. The dry weight, interdialytic weight gain (IDWG), and net ultrafiltration (UF) were calculated from every session of the patient's dialysis, and then taken the average. Blood flow rate (BFR) and dialysate temperature were taken from the largest value from each dialysis session and the greatest frequency. Single pool KT/V and blood tests (hemoglobin, serum albumin, electrolytes) were from the closest value before entering the research. Pre-dialysis systolic blood pressure (SBP) and diastolic blood pressure (DBP) were the average values.
- Volunteers were randomly assigned to two groups, each consisting of 45 individuals. Group 1 underwent BIA measurements monthly for 4 months, then switched to bi-monthly BIA measurements for 4 months. Group 2 underwent BIA measurements every 2 months for 4 months, then switched to monthly BIA measurements for 4 months. Data were used as a combination to adjust dry weight for accurate fluid removal.
- Episodes of intra-dialyltic hypotension were recorded and the numbers of such episodes were calculated as incidence rates to explore the most optimum frequency of BIA measurement (between every-1-month group and the every-2-month). Intradialytic hypotension in this study was defined as a decrease in (SBP) ≥ 20 mmHg or a decrease in mean arterial pressure (MAP) ≥ 10 mmHg. For BIA measurements in addition to the presence of intradialytic hypotension, the number of occurrences of intradialytic hypotension was counted as one increase.
- Factors affecting intradialytic hypotension were also explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the first group (every-1-month BIA and then every-2-month BIA) | Experimental | Device: Bioelectrical Impedance Analysis (BIA)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 | Device: Bioelectrical Impedance Analysis (BIA)measure Bioelectrical Impedance analysis (BIA) for patients' dry weight every 2 months for 4 months, and then every 1 month for 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 18 years of age
- dialysis vintage ≥ 3 months
- hemodialysis at least thrice weekly
- hemodialysis ≥ 3 hours per session.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioelectrical Impedance Analysis (BIA)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. | Device | 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) |
Primary outcome
incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA
Time frame: 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).
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.
1 secondary outcome
factors affecting intra-dialytic hypotension
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 25171342Zhang 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.
- Results publication: PubMed 19153263Agarwal 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.
- Results publication: PubMed 21546884Breidthardt 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.
- Results publication: PubMed 31661683Lee 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.
- Results publication: PubMed 33391741Kanbay 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.
- Results publication: PubMed 33891656Kim 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.
- Results publication: PubMed 15380917Kyle 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.
- Results publication: PubMed 34139470Brunani 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.
- Individual participant dataSharing planned: No. There was no plan to share IPD to other researchers. We used IPD in internal work only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aphichat Chatkrailert, M.D. principal investigator
Thammasat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical Impedance Analysis (BIA) in people with Intradialytic Hypotension and End Stage Renal Disease on Dialysis, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06279156, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.