Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06279156
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension
Sponsor:
Thammasat University Hospital
Organization:
Study Overview
Official Title:
Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: