Effect of Intradialytic Eating Timing on Hemodynamic Stability and Dialysis Adequacy in Hemodialysis Patients

NCT07464418 | Completed

• 1 other identifier: RTM-IDE-HD-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; End-stage Renal Disease (ESRD); Hemodialysis

Keywords

Intradialytic eating; Meal timing during hemodialysis; Hemodynamic stability; Dialysis adequacy

Outcome Measures

Primary Outcomes (4)

• Systolic Blood Pressure

  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.

  Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)

• Diastolic Blood Pressure

  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.

  Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)

• Mean Arterial Pressure

  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.

  Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)

• Heart Rate

  Heart rate, measured in beats per minute (bpm), was monitored during hemodialysis sessions to assess cardiovascular responses associated with different intradialytic eating times.

  Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)

Secondary Outcomes (1)

• Hemodialysis Adequacy (Kt/V)

  At the end of each 4-hour hemodialysis session (sessions 1-4)

Study Arms (2)

Structured Intradialytic Eating Timing

EXPERIMENTAL

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.

Behavioral: Intradialytic Eating Timing Intervention

Standard Care (Control)

NO INTERVENTION

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.

Interventions

Intradialytic Eating Timing Intervention BEHAVIORAL

A structured dietary timing intervention in which standardized meals are provided to participants during hemodialysis at predefined time points across four sessions: first hour, second hour, third hour, and fourth hour of the dialysis session. The nutritional content and portion size are standardized across sessions. The intervention is designed to evaluate the effects of meal timing on hemodynamic stability (blood pressure, mean arterial pressure, heart rate) and hemodialysis adequacy (Kt/V).

Also known as: Structured Intradialytic Meal Timing Timed, Intradialytic Nutrition Protocol

Structured Intradialytic Eating Timing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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."

Sponsors & Collaborators

• Universitas Muhammadiyah Surakarta: lead

Study Sites (1)

Fik Ums

Pacitan, East Java, 63572, Indonesia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to one of two parallel groups: an intervention group and a control group. The intervention group will receive structured intradialytic meals administered at different time points during hemodialysis sessions (first, second, third, and fourth hour across sessions), while the control group will receive standard care without structured meal timing intervention. Outcomes will be measured repeatedly during multiple hemodialysis sessions to evaluate hemodynamic stability and dialysis adequacy.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 11, 2026
• Study Start: January 22, 2026
• Primary Completion: February 2, 2026
• Study Completion: February 20, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)