Pressure Ulcer (PU)NCT07825727
Evaluation of Pressure Injury Risks in Hemofiltration
A study testing Identifying the risks of pressure injuries in people with Pressure Ulcer (PU) and Hemofiltration, run by Ogr. Uyesi Naile at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Patients treated in intensive care units are at high risk of developing pressure injuries due to their critical illnesses as well as many risk factors such as immobility, changes in level of consciousness, hemodynamic instability, mechanical ventilation, sedative and vasoactive drug use, nutritional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer (PU), Hemofiltration, Intensive Care Units (ICUs)
- What is being tested?
- Identifying the risks of pressure injuries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 15 Aug 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age,
- Undergoing hemofiltration,
- Patients whose participation in the study has been approved by their legal representative.
Who cannot join
- Planned intensive care unit stay of less than 48 hours,
- Patients with impaired skin integrity due to different special treatments other than hemofiltration therapy (treatments such as ECMO, VAC, TPN, high-dose vasopressors that impair skin integrity not related to hemofiltration). (These non-hemofiltration-related impairments will be distinguished from the patient's medical history, nursing observation notes, and the opinion of the intensive care specialist. The clinical course in the patient's file will be used to determine the underlying cause.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pressure Injury Risks in Patients Undergoing Hemofiltration in Intensive Care Units
Purpose: Patients treated in intensive care units are at high risk of developing pressure injuries due to their critical illnesses as well as many risk factors such as immobility, changes in level of consciousness, hemodynamic instability, mechanical ventilation, sedative and vasoactive drug use, nutritional deficiencies and long-term hospitalization. In patients receiving hemofiltration treatment, the long duration of treatment, exposure to medical devices, limitation of movement and the severity of the clinical condition may further increase this risk. Pressure injuries can negatively affect the patient's quality of life, increase the duration of care and health care costs, and lead to significant complications. Therefore, it is important to determine the risks of pressure injuries in intensive care patients receiving hemofiltration at an early stage and to reveal risk-related factors. The aim of this study is to evaluate the risks of pressure injury in patients receiving hemofiltration therapy in the intensive care unit and to determine the clinical and treatment-specific factors associated with the development of pressure injury.
Method: The research was planned as descriptive. The study will be carried out between 15 July 2025 and 1 July 2026 by Prof. Dr. It is planned to be carried out in Süleyman Yalçın City Hospital Anesthesia and Reanimation Intensive Care Unit. The population of the research will consist of patients who will receive hemofiltration treatment in the intensive care unit between the specified dates. The sample size was calculated based on logistic regression analysis using the G*Power 3.1 program; It was determined that a minimum of 109 participants should be reached, taking into account the 5% significance level, over 95% statistical power and OR = 2.5 effect size. Patients who are 18 years of age or older, receive hemofiltration, and are approved to participate in the research by their legal representatives will be included in the study. Patients whose planned intensive care unit stay is less than 48 hours and whose skin integrity is impaired due to special treatments other than hemofiltration will be excluded from the study.
Read more
Data will be collected using the Intensive Care Clinical Observation and Patient Information Form created by the researchers, as well as the Glasgow Coma Scale (GCS), Richmond Agitation-Sedation Scale (RASS), APACHE II, Braden Pressure Sore Risk Assessment Scale and Medical Device-Dependent Pressure Sore Risk Assessment Scale. Clinical characteristics of the patients, such as age, gender, height, weight, body mass index, diagnosis and reason for hospitalization, length of stay in the intensive care unit, smoking history, mechanical ventilation status and parameters, diet, frequency of positioning, medications used and paralytic agents will be recorded. In addition, daily blood gas measurements and albumin, hemoglobin, CRP and other relevant laboratory values will be evaluated. Patients' clinical and treatment-related data will be recorded on the first day, last day of hemofiltration and 72 hours after leaving treatment.
Skin integrity and pressure injury development will be evaluated on the first day, last day of hemofiltration and 72 hours after leaving treatment, taking into account EPUAP and NPIAP guidelines. The presence, location, size, stage, infection status and clinical symptoms of the pressure injury will be recorded. General risk of pressure injury by Braden Scale; With the Medical Device-related Pressure Sore Risk Assessment Scale, the risk of pressure injury due to medical devices will be evaluated. Thus, the relationship of variables such as hemofiltration duration, level of consciousness and sedation, disease severity, medical device exposure, positioning frequency, nutritional status and blood parameters with the risk of pressure injury will be examined.
Evaluation of Data: Research data will be analyzed using SPSS 22.0 package program. Descriptive data will be presented as numbers, percentages, mean and standard deviation. Chi-Square and Fisher exact tests will be used to compare categorical variables in independent groups. Logistic regression analysis will be performed to determine the independent factors affecting the development of pressure injury. Statistical significance level will be accepted as p<0.05.
Conclusion: The findings from this study are expected to contribute to the identification of important risk factors for pressure injuries in intensive care patients receiving hemofiltration, the early identification of high-risk patients, and the development of risk-based approaches to prevent pressure injuries in nursing care. It is also thought that the study will contribute to intensive care nursing practices and improving patient safety in terms of evaluating the risk of pressure injury due to medical devices.
- Being tested
- Identifying the risks of pressure injuries
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identifying the risks of pressure injuriesOther
The main clinical practice examined in the study is hemofiltration treatment applied to patients in the intensive care unit in accordance with the physician's decision. Hemofiltration is one of the renal replacement therapies used to regulate fluid and metabolic balance in critically ill patients. In the study, no intervention will be made regarding the application of hemofiltration treatment, and the duration of the treatment, the period in which it is applied and the clinical characteristics of the patient during the treatment process will be recorded in line with the data obtained from routine clinical practices. Hemofiltration duration of patients; It will be evaluated taking into account the first day, last day of treatment and the period 72 hours after the end of hemofiltration treatment. During hemofiltration, the relationship between the patients' level of consciousness and sedation, disease severity, positioning frequency, medical device exposure, nutritional status, medicatio
| Study group | Role | What they receive |
|---|---|---|
| monitoring | Experimental | Not described Receives: Other: Identifying the risks of pressure injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Criterion:
Changes in pressure injury risk levels among patients undergoing hemofiltration will be examined. The Braden risk assessment tool will be used. The Braden Pressure Injury Risk Assessment Scale comprises six sub-dimensions: sensory perception, activity, mobility, moisture, nutrition, and friction and shear. The total score on the scale ranges from 6 to 23. The risk of developing a pressure injury increases as the score decreases.
Measured: the first day of hemofiltration, the last day, and 72 hours after discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Jul 2025
- Primary completion15 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer (PU)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ogr. Uyesi Naile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ogr. Uyesi Naile, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825727
- Sponsor's protocol ID
- Selcuk-YL
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pressure Injury Risks in Patients Undergoing Hemofiltration in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07825727
- Acronym / sponsor ID
- Selcuk-YL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ogr. Uyesi NaileUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 17 Sep 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.
Purpose: Patients treated in intensive care units are at high risk of developing pressure injuries due to their critical illnesses as well as many risk factors such as immobility, changes in level of consciousness, hemodynamic instability, mechanical ventilation, sedative and vasoactive drug use, nutritional deficiencies and long-term hospitalization. In patients receiving hemofiltration treatment, the long duration of treatment, exposure to medical devices, limitation of movement and the severity of the clinical condition may further increase this risk. Pressure injuries can negatively affect the patient's quality of life, increase the duration of care and health care costs, and lead to significant complications. Therefore, it is important to determine the risks of pressure injuries in intensive care patients receiving hemofiltration at an early stage and to reveal risk-related factors. The aim of this study is to evaluate the risks of pressure injury in patients receiving hemofiltration therapy in the intensive care unit and to determine the clinical and treatment-specific factors associated with the development of pressure injury.
Method: The research was planned as descriptive. The study will be carried out between 15 July 2025 and 1 July 2026 by Prof. Dr. It is planned to be carried out in Süleyman Yalçın City Hospital Anesthesia and Reanimation Intensive Care Unit. The population of the research will consist of patients who will receive hemofiltration treatment in the intensive care unit between the specified dates. The sample size was calculated based on logistic regression analysis using the G*Power 3.1 program; It was determined that a minimum of 109 participants should be reached, taking into account the 5% significance level, over 95% statistical power and OR = 2.5 effect size. Patients who are 18 years of age or older, receive hemofiltration, and are approved to participate in the research by their legal representatives will be included in the study. Patients whose planned intensive care unit stay is less than 48 hours and whose skin integrity is impaired due to special treatments other than hemofiltration will be excluded from the study.
Data will be collected using the Intensive Care Clinical Observation and Patient Information Form created by the researchers, as well as the Glasgow Coma Scale (GCS), Richmond Agitation-Sedation Scale (RASS), APACHE II, Braden Pressure Sore Risk Assessment Scale and Medical Device-Dependent Pressure Sore Risk Assessment Scale. Clinical characteristics of the patients, such as age, gender, height, weight, body mass index, diagnosis and reason for hospitalization, length of stay in the intensive care unit, smoking history, mechanical ventilation status and parameters, diet, frequency of positioning, medications used and paralytic agents will be recorded. In addition, daily blood gas measurements and albumin, hemoglobin, CRP and other relevant laboratory values will be evaluated. Patients' clinical and treatment-related data will be recorded on the first day, last day of hemofiltration and 72 hours after leaving treatment.
Skin integrity and pressure injury development will be evaluated on the first day, last day of hemofiltration and 72 hours after leaving treatment, taking into account EPUAP and NPIAP guidelines. The presence, location, size, stage, infection status and clinical symptoms of the pressure injury will be recorded. General risk of pressure injury by Braden Scale; With the Medical Device-related Pressure Sore Risk Assessment Scale, the risk of pressure injury due to medical devices will be evaluated. Thus, the relationship of variables such as hemofiltration duration, level of consciousness and sedation, disease severity, medical device exposure, positioning frequency, nutritional status and blood parameters with the risk of pressure injury will be examined.
Evaluation of Data: Research data will be analyzed using SPSS 22.0 package program. Descriptive data will be presented as numbers, percentages, mean and standard deviation. Chi-Square and Fisher exact tests will be used to compare categorical variables in independent groups. Logistic regression analysis will be performed to determine the independent factors affecting the development of pressure injury. Statistical significance level will be accepted as p<0.05.
Conclusion: The findings from this study are expected to contribute to the identification of important risk factors for pressure injuries in intensive care patients receiving hemofiltration, the early identification of high-risk patients, and the development of risk-based approaches to prevent pressure injuries in nursing care. It is also thought that the study will contribute to intensive care nursing practices and improving patient safety in terms of evaluating the risk of pressure injury due to medical devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| monitoring | Experimental | Other: Identifying the risks of pressure injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years of age,
- Undergoing hemofiltration,
- Patients whose participation in the study has been approved by their legal representative.
Key exclusion criteria (2 listed)
- Planned intensive care unit stay of less than 48 hours,
- Patients with impaired skin integrity due to different special treatments other than hemofiltration therapy (treatments such as ECMO, VAC, TPN, high-dose vasopressors that impair skin integrity not related to hemofiltration). (These non-hemofiltration-related impairments will be distinguished from the patient's medical history, nursing observation notes, and the opinion of the intensive care specialist. The clinical course in the patient's file will be used to determine the underlying cause.)
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 |
|---|---|---|
| Identifying the risks of pressure injuriesThe main clinical practice examined in the study is hemofiltration treatment applied to patients in the intensive care unit in accordance with the physician's decision. Hemofiltration is one of the renal replacement therapies used to regulate fluid and metabolic balance in critically ill patients. In the study, no intervention will be made regarding the application of hemofiltration treatment, and the duration of the treatment, the period in which it is applied and the clinical characteristics of the patient during the treatment process will be recorded in line with the data obtained from routine clinical practices. Hemofiltration duration of patients; It will be evaluated taking into account the first day, last day of treatment and the period 72 hours after the end of hemofiltration treatment. During hemofiltration, the relationship between the patients' level of consciousness and sedation, disease severity, positioning frequency, medical device exposure, nutritional status, medicatio | Other | monitoring |
Primary outcome
Outcome Criterion:
Time frame: the first day of hemofiltration, the last day, and 72 hours after discontinuation
Changes in pressure injury risk levels among patients undergoing hemofiltration will be examined. The Braden risk assessment tool will be used. The Braden Pressure Injury Risk Assessment Scale comprises six sub-dimensions: sensory perception, activity, mobility, moisture, nutrition, and friction and shear. The total score on the scale ranges from 6 to 23. The risk of developing a pressure injury increases as the score decreases.
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 17 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identifying the risks of pressure injuries in people with Pressure Ulcer (PU) and Hemofiltration, run by Ogr. Uyesi Naile 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 2 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 17 Sep 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?
Outcome Criterion: (time frame: the first day of hemofiltration, the last day, and 72 hours after discontinuation). 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 17 Sep 2026.