Dialysis; ComplicationsNCT07412834
Safely Disconnect From the Dialysis Machine in an Emergency Situation
An observational study of Dialysis; Complications, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In a dialysis unit, it is not possible for healthcare personnel to disconnect all patients from the machines simultaneously in the event of an emergency. Therefore, allowing patients who are able to safely disconnect themselves from the machine to do so, while healthcare staff assist those who are unable, will help… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- Emergency withdraw
- How many people
- 620 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 25 Feb 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: This study was conducted in a total of eight dialysis centers: three in Türkiye, two in Portugal, and one each in the Poland, and Greece
Who may be able to join
- Patients aged 18 years and older who had been receiving hemodialysis treatment for at least three months
- Had no conditions that would impair communication
- Voluntarily agreed to participate were included in the study
Who cannot join
- Patients who declined to provide voluntary consent were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Hemodialysis Patients Know How to Safely Disconnect Themselves From the Dialysis Machine in an Emergency Situation?: An International, Multicenter Study
In a dialysis unit, it is not possible for healthcare personnel to disconnect all patients from the machines simultaneously in the event of an emergency. Therefore, allowing patients who are able to safely disconnect themselves from the machine to do so, while healthcare staff assist those who are unable, will help minimize harm during such situations. For this reason, "clamp and cut/cap" training should be provided to all patients, and a note indicating whether the patient is able to disconnect themselves from the machine in an emergency should be included in their medical records. Importantly, this training should not be limited to theoretical instruction but should also include hands-on practice and simulation-based training to reinforce learning and transform knowledge into practical skills.
Read the detailed description
In the literature, only one known study was identified that investigated the level of knowledge of dialysis patients regarding how to disconnect themselves from the machine during a natural disaster. That study reported that only a small proportion of patients knew how to terminate dialysis treatment in an emergency situation. However, the assessment in that study was limited to patients' knowledge level, and the procedural steps of the disconnection process were not evaluated.
Moreover, studies conducted in different countries indicate that dialysis patients have deficiencies in disaster preparedness and emergency procedures, highlighting the need for structured educational programs in this area. To the best of our knowledge, this study will be the first to evaluate both the knowledge level and the procedural steps related to self-disconnection in dialysis patients.
The aim of this study is to assess hemodialysis patients' knowledge regarding how to disconnect themselves from the machine in an emergency situation, as well as the accuracy of the procedural steps involved.
- Conditions
- Dialysis; Complications
- Being tested
- Emergency withdraw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency withdrawOther
A questionnaire was administered to assess patients' level of knowledge regarding self-disconnection from the hemodialysis machine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate information about withdrawal from the machine
Data were collected using a checklist that assessed whether patients knew how to disconnect themselves from the dialysis machine in emergency situations.
Measured: At the begining of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Nov 2025
- Primary completion1 Dec 2025
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul University
- Investigators
- Nurten Ozen, Assoc.Prof., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412834
- Sponsor's protocol ID
- 2025-16
- Status last verified
- May 2026
- First submitted
- 9 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoo KD, Kim HJ, Kim Y, Park JY, Shin SJ, Han SH, Kim DK, Lim CS, Kim YS. Disaster preparedness for earthquakes in hemodialysis units in Gyeongju and Pohang, South Korea. Kidney Res Clin Pract. 2019 Mar 31;38(1):15-24. doi: 10.23876/j.krcp.18.0058.
PubMed 30776874Sever MS, Vanholder R, Lameire N. Disaster preparedness for people with kidney disease and kidney healthcare providers. Curr Opin Nephrol Hypertens. 2024 Nov 1;33(6):613-620. doi: 10.1097/MNH.0000000000001014. Epub 2024 Jul 29.
PubMed 39046087Ozen N, Ozturk S, Dunya CP, Hryszko T, Fernandes F, Vovlianou S, Rotmans JI, Lindhard K, Velarde EC, Parmaksiz E, Kaya D, Kocak SY, Turan F, Celik A, Coban I, Sousa CN, Unver V. An International Multicentre Study of Haemodialysis Patients' Knowledge of Safe Self-Disconnection From the Dialysis Machine in Emergencies. J Ren Care. 2026 Sep;52(3):e70080. doi: 10.1111/jorc.70080.
PubMed 42695541
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Hemodialysis Patients Know How to Safely Disconnect Themselves From the Dialysis Machine in an Emergency Situation?: An International, Multicenter Study
- ClinicalTrials.gov ID
- NCT07412834
- Acronym / sponsor ID
- 2025-16
- Conditions
- Dialysis; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 17 Feb 2026 (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.
In a dialysis unit, it is not possible for healthcare personnel to disconnect all patients from the machines simultaneously in the event of an emergency. Therefore, allowing patients who are able to safely disconnect themselves from the machine to do so, while healthcare staff assist those who are unable, will help minimize harm during such situations. For this reason, "clamp and cut/cap" training should be provided to all patients, and a note indicating whether the patient is able to disconnect themselves from the machine in an emergency should be included in their medical records. Importantly, this training should not be limited to theoretical instruction but should also include hands-on practice and simulation-based training to reinforce learning and transform knowledge into practical skills.
Detailed description
In the literature, only one known study was identified that investigated the level of knowledge of dialysis patients regarding how to disconnect themselves from the machine during a natural disaster. That study reported that only a small proportion of patients knew how to terminate dialysis treatment in an emergency situation. However, the assessment in that study was limited to patients' knowledge level, and the procedural steps of the disconnection process were not evaluated.
Moreover, studies conducted in different countries indicate that dialysis patients have deficiencies in disaster preparedness and emergency procedures, highlighting the need for structured educational programs in this area. To the best of our knowledge, this study will be the first to evaluate both the knowledge level and the procedural steps related to self-disconnection in dialysis patients.
The aim of this study is to assess hemodialysis patients' knowledge regarding how to disconnect themselves from the machine in an emergency situation, as well as the accuracy of the procedural steps involved.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in a total of eight dialysis centers: three in Türkiye, two in Portugal, and one each in the Poland, and Greece
Key inclusion criteria (3 listed)
- Patients aged 18 years and older who had been receiving hemodialysis treatment for at least three months
- Had no conditions that would impair communication
- Voluntarily agreed to participate were included in the study
Key exclusion criteria (1 listed)
- Patients who declined to provide voluntary consent were excluded from the study
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 |
|---|---|---|
| Emergency withdrawA questionnaire was administered to assess patients' level of knowledge regarding self-disconnection from the hemodialysis machine. | Other | – |
Primary outcome
Adequate information about withdrawal from the machine
Time frame: At the begining of the study
Data were collected using a checklist that assessed whether patients knew how to disconnect themselves from the dialysis machine in emergency situations.
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 5 May 2026.
- Results publication: PubMed 30776874Yoo KD, Kim HJ, Kim Y, Park JY, Shin SJ, Han SH, Kim DK, Lim CS, Kim YS. Disaster preparedness for earthquakes in hemodialysis units in Gyeongju and Pohang, South Korea. Kidney Res Clin Pract. 2019 Mar 31;38(1):15-24. doi: 10.23876/j.krcp.18.0058.
- Results publication: PubMed 39046087Sever MS, Vanholder R, Lameire N. Disaster preparedness for people with kidney disease and kidney healthcare providers. Curr Opin Nephrol Hypertens. 2024 Nov 1;33(6):613-620. doi: 10.1097/MNH.0000000000001014. Epub 2024 Jul 29.
- Derived from this study: PubMed 42695541Ozen N, Ozturk S, Dunya CP, Hryszko T, Fernandes F, Vovlianou S, Rotmans JI, Lindhard K, Velarde EC, Parmaksiz E, Kaya D, Kocak SY, Turan F, Celik A, Coban I, Sousa CN, Unver V. An International Multicentre Study of Haemodialysis Patients' Knowledge of Safe Self-Disconnection From the Dialysis Machine in Emergencies. J Ren Care. 2026 Sep;52(3):e70080. doi: 10.1111/jorc.70080.
- Individual participant dataSharing planned: No
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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.
Nurten Ozen, Assoc.Prof. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis; Complications, run by Istanbul 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 3 inclusion and 1 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 5 May 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?
Adequate information about withdrawal from the machine (time frame: At the begining of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412834, which also lists 3 linked publications.
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 5 May 2026.