Lower Dialysate Temperature and Post-Dialysis Fatigue

NCT07071376 | Completed DMC

• 1 other identifier: Dialysis
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis Related Complication

Keywords

dialysis; cold dialysis; fatique

Outcome Measures

Primary Outcomes (1)

• Post-dialysis fatigue scale

  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.

  1 week

Secondary Outcomes (1)

• Thermal comfort perception

  1 week

Study Arms (1)

Cold Dialysis

EXPERIMENTAL

To be applied with cold dialysis

Other: cold dialysis

Interventions

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.

Cold Dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Türkiye, 109861, Turkey (Türkiye)

Location

Study Officials

• Gülay Turgay

  Baskent Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Cold dialysis group

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 17, 2025
• Study Start: May 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: September 15, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

TU (1)