Chronic Kidney DiseaseIDE-HDNCT07464418
Effect of Intradialytic Eating Timing on Hemodynamic Stability and Dialysis Adequacy in Hemodialysis Patients
A study testing Intradialytic Eating Timing Intervention in people with Chronic Kidney Disease and End-stage Renal Disease (ESRD), run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease, End-stage Renal Disease (ESRD), Hemodialysis
- What is being tested?
- Intradialytic Eating Timing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Jan 2026to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Differences in Intradialytic Eating Time on Hemodynamic Stability and Hemodialysis Adequacy in Patients With Chronic Kidney Disease Undergoing Hemodialysis
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.
Read more
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.
Read the 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.
- Being tested
- Intradialytic Eating Timing Intervention
- Keywords
- Intradialytic eating, Meal timing during hemodialysis, Hemodynamic stability, Dialysis adequacy
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic Eating Timing InterventionBehavioural
Also called Structured Intradialytic Meal Timing Timed, Intradialytic Nutrition Protocol
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)
Secondary outcomes (1)
Hemodialysis Adequacy (Kt/V)
Dialysis adequacy was assessed using the Kt/V parameter, which represents the efficiency of urea clearance during hemodialysis.
Measured: At the end of each 4-hour hemodialysis session (sessions 1-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start22 Jan 2026
- Primary completion2 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Surakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tutut Setiowati, Universitas Muhammadiyah Surakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464418
- Sponsor's protocol ID
- RTM-IDE-HD-2026
- Acronym
- IDE-HD
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, patient confidentiality, and the absence of a formal data-sharing framework for this single-center academic study. Data will be used solely for research, analysis, and publication purposes as approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Differences in Intradialytic Eating Time on Hemodynamic Stability and Hemodialysis Adequacy in Patients With Chronic Kidney Disease Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT07464418
- Acronym / sponsor ID
- IDE-HD / RTM-IDE-HD-2026
- Keywords
- Intradialytic eating, Meal timing during hemodialysis, Hemodynamic stability, Dialysis adequacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SurakartaUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured Intradialytic Eating Timing | Experimental | Behavioral: Intradialytic Eating Timing InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic Eating Timing InterventionAlso: Structured Intradialytic Meal Timing Timed, Intradialytic Nutrition ProtocolA 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). | Behavioural | Structured Intradialytic Eating Timing |
Primary outcome
Systolic Blood Pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Hemodialysis Adequacy (Kt/V)
Time frame: At the end of each 4-hour hemodialysis session (sessions 1-4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, patient confidentiality, and the absence of a formal data-sharing framework for this single-center academic study. Data will be used solely for research, analysis, and publication purposes as approved by the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic Eating Timing Intervention in people with Chronic Kidney Disease and End-stage Renal Disease (ESRD), run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.