The Effect of Differences in Intradialytic Eating Time on Hemodynamic Stability and Hemodialysis Adequacy in Patients With Chronic Kidney Disease Undergoing Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not applicable. This is an open-label study due to the nature of the dietary timing intervention, which cannot be blinded to participants, care providers, or investigators.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years
- •Diagnosed with chronic kidney disease (CKD)
- •Undergoing regular maintenance hemodialysis
- •Receiving hemodialysis on a routine schedule (e.g., twice weekly)
- •Clinically stable during hemodialysis
- •Able to eat orally during dialysis sessions
- •Willing to participate and provide informed consent
排除标准
- •Patients with pre-dialysis with acute or severe cardiovascular conditions,, those receiving enteral/parenteral nutrition, with cognitive impairment, or who refuse or withdraw informed consent will be excluded."
研究组 & 干预措施
Structured Intradialytic Eating Timing
Participants receive standardized meals during hemodialysis at predefined time points across four sessions: first hour, second hour, third hour, and fourth hour of the dialysis session. Hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate) are measured every 30 minutes during each session. Dialysis adequacy is evaluated using the Kt/V parameter to assess the effect of meal timing on hemodynamic stability and dialysis efficiency.
干预措施: Intradialytic Eating Timing Intervention (Behavioral)
Standard Care (Control)
Participants receive routine hemodialysis care without structured intradialytic eating timing. Patients continue their usual eating and drinking habits during dialysis according to standard clinical practice. Hemodynamic parameters and dialysis adequacy are measured using the same procedures and time intervals as the intervention group.
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)
Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg), was recorded during hemodialysis sessions to evaluate hemodynamic responses associated with different intradialytic eating times.
Diastolic Blood Pressure
时间窗: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)
Diastolic blood pressure (DBP), measured in millimeters of mercury (mmHg), was recorded during hemodialysis sessions to evaluate hemodynamic responses associated with different intradialytic eating times.
Mean Arterial Pressure
时间窗: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)
Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), was calculated from systolic and diastolic blood pressure measurements to assess circulatory stability during hemodialysis sessions.
Heart Rate
时间窗: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)
Heart rate, measured in beats per minute (bpm), was monitored during hemodialysis sessions to assess cardiovascular responses associated with different intradialytic eating times.
次要结局
- Hemodialysis Adequacy (Kt/V)(At the end of each 4-hour hemodialysis session (sessions 1-4))
研究者
Tutut Setiowati
Principal Investigator
Universitas Muhammadiyah Surakarta