Dialysis Related ComplicationNCT07071376
Lower Dialysate Temperature and Post-Dialysis Fatigue
A study testing cold dialysis in people with Dialysis Related Complication, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dialysis Related Complication
- What is being tested?
- cold dialysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lower Dialysate Temperature on Post-Dialysis Fatigue in Patients Receiving Maintenance Hemodialysis
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.
Read the 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.
- Conditions
- Dialysis Related Complication
- Being tested
- cold dialysis
- Keywords
- dialysis, cold dialysis, fatique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold dialysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Dialysis | Experimental | To be applied with cold dialysis Receives: Other: cold dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
Thermal comfort perception
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 May 2025
- Primary completion15 Jun 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Related ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cold dialysis group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Turgay, Baskent University
- Investigators
- Gülay Turgay, Study director, Baskent Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071376
- Sponsor's protocol ID
- Dialysis
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Dialysate Temperature on Post-Dialysis Fatigue in Patients Receiving Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT07071376
- Acronym / sponsor ID
- Dialysis
- Conditions
- Dialysis Related Complication
- Keywords
- dialysis, cold dialysis, fatique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cold dialysis group
| Arm | Type | Receives |
|---|---|---|
| Cold Dialysis | Experimental | Other: cold dialysisTo be applied with cold dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold dialysisPatients 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. | Other | Cold Dialysis |
Primary outcome
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.
1 secondary outcome
Thermal comfort perception
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Turgay study director
Baskent Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold dialysis in people with Dialysis Related Complication, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dialysis fatigue scale (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.