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Lower Dialysate Temperature and Post-Dialysis Fatigue

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07071376
Enrollment
57
Registered
2025-07-17
Start date
2025-05-15
Completion date
2025-09-15
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Related Complication

Keywords

dialysis, cold dialysis, fatique

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Cold dialysis group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-dialysis fatigue scale1 weekA 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

MeasureTime frameDescription
Thermal comfort perception1 weekPatients' 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.

Countries

Turkey (Türkiye)

Contacts

STUDY_DIRECTORGülay Turgay

Baskent Universitesi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026