Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06279156
Other study ID # MTU-EC-IM-0-014/65
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date February 28, 2023

Study information

Verified date March 2024
Source Thammasat University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Thailand Thammasat University Hospital Pathum Thani

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

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

Outcome

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).
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05978479 - The Effect of Individualized Education Using the Teach-Back Method Treatment on Treatment Adherence and the Coping Skills N/A
Completed NCT06022835 - Chlorhexidine Gluconate-gel Dressing for Exit Site Infection in Peritoneal Dialysis N/A
Completed NCT05540457 - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) N/A
Recruiting NCT04046042 - Virtual Reality Intradialysis: Last vs. First Part of the Session N/A
Not yet recruiting NCT04527640 - Effects of Synbiotics Supplementation on the Uremic Toxin Indoxyl Sulfate Level and Constipation in End-stage Renal Disease Patients Undergoing Hemodialysis N/A
Completed NCT05947708 - The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300 N/A
Recruiting NCT05735743 - MoVE Trial: Motivational Strategies to Empower African Americans to Improve Dialysis Adherence N/A
Completed NCT04505462 - Dietary Therapy in Dialysis Patients N/A
Active, not recruiting NCT04546958 - Nutritional Interventions in Peritoneal Dialysis Patients With Hypoalbuminemia N/A
Recruiting NCT04286477 - The Immune System in End Stage CKD Patients - Comparison Among Different Modalities of RRT
Completed NCT04487301 - A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
Recruiting NCT05677555 - Colchicine and Inflammation in Hemodialysis Patients Phase 2
Completed NCT04789876 - Effectiveness of The Phosphate Mobile App on Serum Phosphorus in Adult Hemodialysis Patients With Hyperphosphatemia N/A
Completed NCT04125537 - Pathways Project: Kidney Supportive Care
Suspended NCT05915286 - Diuretic Use in Hemodialysis Patients With Residual Renal Function Phase 4
Completed NCT04912050 - EXtension of Tablo TrEatmeNt Duration Registry
Recruiting NCT04360694 - RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE) N/A
Recruiting NCT04501159 - pH, Hypoxia and Haemodialysis
Recruiting NCT05032651 - Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients N/A
Completed NCT04806126 - Evaluation of a Virtual Home Dialysis Mentoring Program (Home)