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NCT Number: NCT07071376

Lower Dialysate Temperature and Post-Dialysis Fatigue

The standard dialysate temperature is usually set at 36.5°C in hemodialysis applications. Since this temperature is close to the patient's body temperature, it is ideal for preventing the patient from experiencing hypothermia while ensuring cardiovascular stability. In the literature, it is seen that changing the dialysate temperature, especially cold dialysis applications, is used in the management of nausea, the effect on vital signs, determining hemodialysis adequacy and common complications, and in the management of symptoms such as hypotension, cardiac stability, vascular stability, fatigue, and muscle cramps. However, no study has been found using cold dialysis in the management of fatigue that develops after dialysis.Therefore, the aim of this study is to examine the effect of cold dialysis application on post-dialysis fatigue in patients receiving hemodialysis treatment.

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Key information

Conditions

Dialysis Related Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University

Ankara, Türkiye, 109861, Turkey (Türkiye)

About this study

The purpose of the study is to examine the effect of cold dialysis application on post-dialysis fatigue in patients receiving hemodialysis treatment.

Research Hypothesis

H1: Reduced dialysate temperature may improve post-dialysis fatigue without compromising thermal comfort

METHOD

Research Design

This study was designed as a single group pre-test-post-test experimental design.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who agreed to participate in the study
  • Age 18 and over
  • Having been on hemodialysis for at least 6 months
  • Having hemodialysis 3 times a week
  • Having a post-dialysis fatigue score ≥28.

Exclusion criteria

  • Having an active infection
  • Having a body temperature above 37.5°C
  • Having serious cardiovascular diseases (e.g., uncontrolled hypertension, congestive heart failure)
  • Having a history of acute complications during dialysis
  • Having a history of severe hypotension
  • Patients whose dialysis treatment was interrupted

Treatment and study plan

cold dialysis

Other

Patients who meet the inclusion criteria will receive 3 sessions of cold dialysis treatment by reducing the dialysate temperature from 36.5°C to 36°C. Patients will receive this treatment for 1 week, i.e. 3 dialysis sessions. Each dialysis session will last 4 hours. During each dialysis session, the thermal comfort status of the patients will be evaluated by applying the numeric visual analog scale (NVAS) at the beginning of dialysis, at the 1st, 2nd, 3rd, 4th hours of dialysis and at the end of dialysis. In addition, the day after each session, the patients will be called by phone and the Postdialysis Fatigue Scale will be re-administered and their fatigue levels will be evaluated.

Primary outcomes

  1. Post-dialysis fatigue scale

    Time frame: 1 week

    A minimum score of 11 and a maximum score of 55 is obtained from this scale, and an increase in the score indicates an increase in the severity of fatigue.

Secondary outcomes

  1. Thermal comfort perception

    Time frame: 1 week

    Patients' thermal comfort perception was assessed using a numeric visual analog scale (NVAS) as described by Wagner et al. The scale ranges from 0 (extreme cold) to 10 (extreme heat), with the midpoint value of 5 indicating thermal neutrality (i.e., optimal thermal comfort). Participants were asked to mark the point on the scale that best reflected their perceived thermal comfort.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Effect of Lower Dialysate Temperature on Post-Dialysis Fatigue in Patients Receiving Maintenance Hemodialysis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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