Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-29 @ 11:57 PM
Study NCT ID:
NCT07464418
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intradialytic Eating Timing on Hemodynamic Stability and Dialysis Adequacy in Hemodialysis Patients
Sponsor:
Universitas Muhammadiyah Surakarta
Organization:
Study Overview
Official Title:
The Effect of Differences in Intradialytic Eating Time on Hemodynamic Stability and Hemodialysis Adequacy in Patients With Chronic Kidney Disease Undergoing Hemodialysis
Status:
COMPLETED
Status Verified Date:
2026-03
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:
IDE-HD
Brief Summary:
This study aims to examine how different meal timing during hemodialysis affects blood pressure stability and dialysis effectiveness in patients with chronic kidney disease. Many patients eat during hemodialysis sessions to maintain their nutritional status, but eating during treatment may affect blood pressure and the body's ability to remove toxins and excess fluid effectively. At present, there is no clear guideline about the safest and most effective time to eat during hemodialysis.
This study will involve patients with chronic kidney disease who undergo regular hemodialysis. Participants will be divided into two groups: an intervention group and a control group. The intervention group will receive meals at different time points during hemodialysis sessions, while the control group will continue their usual eating habits without structured meal timing intervention.
Blood pressure, heart rate, and mean arterial pressure will be measured repeatedly during dialysis sessions to assess hemodynamic stability. Dialysis adequacy will be evaluated using the Kt/V parameter. The results of this study are expected to identify the safest and most effective time for eating during hemodialysis in order to maintain stable blood pressure and ensure adequate dialysis treatment.
This study is expected to provide evidence-based guidance for healthcare providers in managing intradialytic eating practices and improving patient safety, treatment quality, and clinical outcomes in hemodialysis care.
This study will involve patients with chronic kidney disease who undergo regular hemodialysis. Participants will be divided into two groups: an intervention group and a control group. The intervention group will receive meals at different time points during hemodialysis sessions, while the control group will continue their usual eating habits without structured meal timing intervention.
Blood pressure, heart rate, and mean arterial pressure will be measured repeatedly during dialysis sessions to assess hemodynamic stability. Dialysis adequacy will be evaluated using the Kt/V parameter. The results of this study are expected to identify the safest and most effective time for eating during hemodialysis in order to maintain stable blood pressure and ensure adequate dialysis treatment.
This study is expected to provide evidence-based guidance for healthcare providers in managing intradialytic eating practices and improving patient safety, treatment quality, and clinical outcomes in hemodialysis care.
Detailed Description:
This study is a quasi-experimental clinical trial using a non-equivalent control group design to evaluate the effect of different intradialytic eating times on hemodynamic stability and hemodialysis adequacy in patients with chronic kidney disease undergoing regular hemodialysis.
Hemodynamic instability, particularly intradialytic hypotension, is a common complication during hemodialysis and is associated with poor clinical outcomes, reduced dialysis efficiency, and increased cardiovascular risk. Intradialytic eating is widely practiced in many hemodialysis centers to support nutritional intake and prevent protein-energy wasting. However, previous studies have reported conflicting findings regarding its effects on blood pressure stability and dialysis adequacy. Some evidence suggests that postprandial splanchnic blood redistribution may contribute to blood pressure reduction and impaired solute clearance, while other studies emphasize nutritional benefits and improved patient well-being. Currently, there is no standardized guideline regarding optimal meal timing during hemodialysis.
This study is designed to address this clinical gap by systematically evaluating the effect of meal timing during dialysis on hemodynamic and dialysis adequacy parameters.
Participants will be adult patients with chronic kidney disease undergoing routine hemodialysis. A total of 40 participants will be enrolled and allocated into two groups:
Intervention group - patients will receive standardized meals at different time points during four hemodialysis sessions, with meal timing structured as follows: first hour, second hour, third hour, and fourth hour of the dialysis session across consecutive sessions.
Control group - patients will receive standard care and continue their usual eating and drinking habits during dialysis without structured intervention.
Hemodynamic parameters will be assessed repeatedly every 30 minutes during each dialysis session, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. Hemodynamic stability will be evaluated based on blood pressure variability and changes during dialysis sessions.
Dialysis adequacy will be assessed using the Kt/V parameter, which reflects urea clearance efficiency and treatment adequacy.
Data will be analyzed to compare within-group and between-group differences in hemodynamic trends and dialysis adequacy across sessions. Repeated measures statistical analysis will be used to evaluate temporal changes in hemodynamic parameters and treatment adequacy associated with different intradialytic eating times.
The findings of this study are expected to identify an optimal and safe timing for intradialytic eating that minimizes hemodynamic instability while maintaining adequate dialysis efficiency. The results will provide clinically relevant evidence to support the development of standardized guidelines for intradialytic nutrition practices, contribute to safer dialysis care, and improve clinical outcomes for patients undergoing long-term hemodialysis.
Hemodynamic instability, particularly intradialytic hypotension, is a common complication during hemodialysis and is associated with poor clinical outcomes, reduced dialysis efficiency, and increased cardiovascular risk. Intradialytic eating is widely practiced in many hemodialysis centers to support nutritional intake and prevent protein-energy wasting. However, previous studies have reported conflicting findings regarding its effects on blood pressure stability and dialysis adequacy. Some evidence suggests that postprandial splanchnic blood redistribution may contribute to blood pressure reduction and impaired solute clearance, while other studies emphasize nutritional benefits and improved patient well-being. Currently, there is no standardized guideline regarding optimal meal timing during hemodialysis.
This study is designed to address this clinical gap by systematically evaluating the effect of meal timing during dialysis on hemodynamic and dialysis adequacy parameters.
Participants will be adult patients with chronic kidney disease undergoing routine hemodialysis. A total of 40 participants will be enrolled and allocated into two groups:
Intervention group - patients will receive standardized meals at different time points during four hemodialysis sessions, with meal timing structured as follows: first hour, second hour, third hour, and fourth hour of the dialysis session across consecutive sessions.
Control group - patients will receive standard care and continue their usual eating and drinking habits during dialysis without structured intervention.
Hemodynamic parameters will be assessed repeatedly every 30 minutes during each dialysis session, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate. Hemodynamic stability will be evaluated based on blood pressure variability and changes during dialysis sessions.
Dialysis adequacy will be assessed using the Kt/V parameter, which reflects urea clearance efficiency and treatment adequacy.
Data will be analyzed to compare within-group and between-group differences in hemodynamic trends and dialysis adequacy across sessions. Repeated measures statistical analysis will be used to evaluate temporal changes in hemodynamic parameters and treatment adequacy associated with different intradialytic eating times.
The findings of this study are expected to identify an optimal and safe timing for intradialytic eating that minimizes hemodynamic instability while maintaining adequate dialysis efficiency. The results will provide clinically relevant evidence to support the development of standardized guidelines for intradialytic nutrition practices, contribute to safer dialysis care, and improve clinical outcomes for patients undergoing long-term hemodialysis.
Study Oversight
Has Oversight DMC:
False
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?: