Effects of Intradialytic Nutrition on Dialysis Adequacy and Fatigue

NCT07687498 | Completed

• 1 other identifier: MEU-MG-HF-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

End-Stage Kidney Disease (ESKD); Hemodialysis

Keywords

Hemodialysis; Nutrition; Fatigue; Urea; Kinetics

Outcome Measures

Primary Outcomes (3)

• Dialysis Adequacy (spKt/V)

  Dialysis adequacy was assessed using single-pool Kt/V (spKt/V)

  At the end of each 4-week study period.

• Urea Reduction Ratio (URR)

  Urea Reduction Ratio (URR) calculated from routine pre- and post-dialysis blood samples.

  Assessed at the end of each 4-week study period.

• Fatigue Severity

  Piper Fatigue Scale (22 items; total score 0-220). Higher scores indicate greater fatigue severity (worse fatigue).

  Assessed at the end of each 4-week study period.

Secondary Outcomes (2)

• Intradialytic Systolic Blood Pressure

  During each dialysis session throughout each 4-week study period.

• Intradialytic Diastolic Blood Pressure

  During each dialysis session throughout each 4-week study period.

Study Arms (2)

Standardized Intradialytic Nutrition

EXPERIMENTAL

Participants received a standardized renal meal during hemodialysis sessions.

Dietary Supplement: Standardized Intradialytic Nutrition

No Intradialytic Food Intake

NO INTERVENTION

Participants did not consume food during hemodialysis sessions.

Interventions

Standardized Intradialytic Nutrition DIETARY_SUPPLEMENT

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.

Standardized Intradialytic Nutrition

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (2)

Diamer Private Dialysis Center

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Mersin University, Faculty of Medicine Hospital, Hemodialysis Unit

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Signs and Symptoms

Study Officials

• Esra Köse, MSc

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesör

Model Details: 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)

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start: April 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)