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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Fenerbahce University

    Istanbul

Other trials in Turkey (Türkiye)

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 groups in NCT07825727
Study groupRoleWhat they receive
monitoringExperimentalNot 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.

  1. 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.

  1. First posted17 Sep 2026
  2. Study start15 Jul 2025
  3. Primary completion15 Jul 2026
  4. Study completion15 Aug 2026

Resources

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)
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

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.

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