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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)', 'description': '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.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)', 'description': '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.'}, {'measure': 'Mean Arterial Pressure', 'timeFrame': 'Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)', 'description': '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.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline (start of hemodialysis) and every 30 minutes during each 4-hour hemodialysis session (sessions 1-4)', 'description': 'Heart rate, measured in beats per minute (bpm), was monitored during hemodialysis sessions to assess cardiovascular responses associated with different intradialytic eating times.'}], 'secondaryOutcomes': [{'measure': 'Hemodialysis Adequacy (Kt/V)', 'timeFrame': 'At the end of each 4-hour hemodialysis session (sessions 1-4)', 'description': 'Dialysis adequacy was assessed using the Kt/V parameter, which represents the efficiency of urea clearance during hemodialysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intradialytic eating', 'Meal timing during hemodialysis', 'Hemodynamic stability', 'Dialysis adequacy'], 'conditions': ['Chronic Kidney Disease', 'End-stage Renal Disease (ESRD)', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nBlood 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.\n\nThis 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.", 'detailedDescription': '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.\n\nHemodynamic 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.\n\nThis study is designed to address this clinical gap by systematically evaluating the effect of meal timing during dialysis on hemodynamic and dialysis adequacy parameters.\n\nParticipants will be adult patients with chronic kidney disease undergoing routine hemodialysis. A total of 40 participants will be enrolled and allocated into two groups:\n\nIntervention 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.\n\nControl group - patients will receive standard care and continue their usual eating and drinking habits during dialysis without structured intervention.\n\nHemodynamic 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.\n\nDialysis adequacy will be assessed using the Kt/V parameter, which reflects urea clearance efficiency and treatment adequacy.\n\nData 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged ≥ 18 years\n2. Diagnosed with chronic kidney disease (CKD)\n3. Undergoing regular maintenance hemodialysis\n4. Receiving hemodialysis on a routine schedule (e.g., twice weekly)\n5. Clinically stable during hemodialysis\n6. Able to eat orally during dialysis sessions\n7. Willing to participate and provide informed consent\n\nExclusion Criteria:\n\nPatients 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."'}, 'identificationModule': {'nctId': 'NCT07464418', 'acronym': 'IDE-HD', 'briefTitle': 'Effect of Intradialytic Eating Timing on Hemodynamic Stability and Dialysis Adequacy in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Muhammadiyah Surakarta'}, 'officialTitle': 'The Effect of Differences in Intradialytic Eating Time on Hemodynamic Stability and Hemodialysis Adequacy in Patients With Chronic Kidney Disease Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'RTM-IDE-HD-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Structured Intradialytic Eating Timing', 'description': '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.', 'interventionNames': ['Behavioral: Intradialytic Eating Timing Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care (Control)', 'description': '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': [{'name': 'Intradialytic Eating Timing Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Structured Intradialytic Meal Timing Timed', 'Intradialytic Nutrition Protocol'], 'description': '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).', 'armGroupLabels': ['Structured Intradialytic Eating Timing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63572', 'city': 'Pacitan', 'state': 'East Java', 'country': 'Indonesia', 'facility': 'Fik Ums', 'geoPoint': {'lat': -8.1095, 'lon': 112.0162}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Muhammadiyah Surakarta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tutut Setiowati', 'investigatorAffiliation': 'Universitas Muhammadiyah Surakarta'}}}}