End-Stage Kidney Disease (ESKD), Hemodialysis
Conditions
Keywords
Hemodialysis, Nutrition, Fatigue, Urea, Kinetics
Brief summary
This randomized, two-period, two-sequence crossover trial aims to evaluate the effects of intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic parameters, and fatigue in adults receiving maintenance hemodialysis. Participants will receive standardized intradialytic nutrition during one study period and no food intake during the other period, with each participant serving as their own control. Dialysis adequacy will be assessed using the urea reduction ratio (URR) and single-pool Kt/V (spKt/V), while fatigue will be evaluated using the Piper Fatigue Scale. Intradialytic blood pressure and other clinical parameters will also be monitored throughout the study. The findings are expected to provide evidence regarding the safety and clinical effects of intradialytic nutrition and to support individualized nutritional management strategies for patients undergoing maintenance hemodialysis.
Detailed description
Chronic kidney disease is a major global health problem, and maintenance hemodialysis remains the most common renal replacement therapy for patients with end-stage kidney disease. Although hemodialysis prolongs survival, many patients experience treatment-related complications, including intradialytic hypotension, fatigue, and protein-energy wasting, all of which negatively affect quality of life and clinical outcomes. Adequate nutritional intake is essential for preventing malnutrition in patients receiving maintenance hemodialysis. Because many patients have poor appetite before or after dialysis sessions, intradialytic nutrition has been proposed as an opportunity to improve energy and protein intake. However, the safety and clinical effects of eating during hemodialysis remain controversial. Some studies suggest that food intake during dialysis may reduce dialysis efficiency or contribute to intradialytic hypotension through postprandial hemodynamic changes, whereas other studies have reported no clinically meaningful adverse effects. Consequently, current international recommendations advocate an individualized approach rather than routine intradialytic feeding. Fatigue is one of the most common and disabling symptoms experienced by patients undergoing maintenance hemodialysis. Although nutritional status has been associated with fatigue, limited evidence is available regarding the direct effect of intradialytic nutrition on fatigue severity. Furthermore, few randomized crossover studies have simultaneously evaluated dialysis adequacy, hemodynamic responses, and patient-reported fatigue outcomes. This study was designed to provide clinical evidence regarding the effects of standardized intradialytic nutrition on dialysis adequacy, intradialytic hemodynamic stability, and fatigue in adults receiving maintenance hemodialysis. A randomized, two-period, two-sequence crossover design was selected to allow each participant to serve as his or her own control, thereby reducing interindividual variability. The findings are expected to contribute to evidence-based recommendations regarding individualized nutritional practices during hemodialysis and to support clinical decision-making for patients at risk of malnutrition while maintaining treatment safety.
Interventions
DIETARY_SUPPLEMENTStandardized Intradialytic Nutrition
Participants received a standardized renal meal approximately 1.5 hours after the start of each hemodialysis session. The meal provided approximately 450 kcal and 20 g of protein and was designed according to renal dietary recommendations with low potassium and phosphorus content. Participants were instructed to consume the entire meal and not to consume any additional food during the dialysis session.
Sponsors
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants were randomized to one of two sequences in a two-period crossover design. Each participant received both interventions (standardized intradialytic nutrition and no intradialytic food intake) in different periods and served as his or her own control. Arm 1 Arm Title: Standardized Intradialytic Nutrition Arm Type: Experimental Description: Participants received a standardized renal meal during hemodialysis sessions. Intervention Type: Dietary Supplement (veya Other) Intervention Name: Standardized Intradialytic Nutrition Arm 2 Arm Title: No Intradialytic Food Intake Arm Type: No Intervention Description: Participants did not consume food during hemodialysis sessions. Intervention: (No Intervention)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Receiving maintenance hemodialysis three times per week for at least 3 months. * Clinically stable. * Able to provide written informed consent.
Exclusion criteria
* Active infection. * Hospitalization within the previous month. * Gastrointestinal disorders affecting oral intake. * Severe intradialytic hypotension requiring frequent intervention (MAP \<65 mmHg). * Cognitive impairment. * Pregnancy. * Scheduled kidney transplantation with an available donor during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dialysis Adequacy (spKt/V) | At the end of each 4-week study period. | Dialysis adequacy was assessed using single-pool Kt/V (spKt/V) |
| Urea Reduction Ratio (URR) | Assessed at the end of each 4-week study period. | Urea Reduction Ratio (URR) calculated from routine pre- and post-dialysis blood samples. |
| Fatigue Severity | Assessed at the end of each 4-week study period. | Piper Fatigue Scale (22 items; total score 0-220). Higher scores indicate greater fatigue severity (worse fatigue). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intradialytic Systolic Blood Pressure | During each dialysis session throughout each 4-week study period. | Blood pressure was measured before dialysis and hourly during the dialysis session. |
| Intradialytic Diastolic Blood Pressure | During each dialysis session throughout each 4-week study period. | Blood pressure was measured before dialysis and hourly during the dialysis session. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREsra Köse, MSc
Mersin University
Outcome results
None listed