Cold Dialysis in Hemodialysis Patients

NCT ID: NCT07071376

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-08-01

Brief Summary

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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

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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: Cold dialysis application reduces the level of post-dialysis fatigue.

METHOD

Research Design

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

Conditions

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Dialysis Related Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cold dialysis group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold Dialysis

To be applied with cold dialysis

Group Type EXPERIMENTAL

cold dialysis

Intervention Type 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 Temperature Comfort Perception Scale at the beginning of dialysis, at the 1st, 2nd and 3rd 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.

Interventions

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cold dialysis

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 Temperature Comfort Perception Scale at the beginning of dialysis, at the 1st, 2nd and 3rd 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.

Intervention Type OTHER

Eligibility Criteria

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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 high postdialysis fatigue score cut-off point compared to the mean

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Gülay Turgay

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay Turgay

Role: STUDY_DIRECTOR

Baskent Universitesi

Locations

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Baskent University

Ankara, Türkiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Dialysis

Identifier Type: -

Identifier Source: org_study_id

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