Pressure InjuryNCT06860308
The Effect of Norepinephrine on the Development of Pressure Injury
An observational study of Pressure Injury, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Norepinephrine mainly increases mean arterial pressure among intensive care patients. It may be an essential risk factor in developing pressure injuries. However, there are still conflicting findings in the literature. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- Type of treatment
- Injection or infusion
- How many people
- 289 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 20 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population included all adult critically ill patients hospitalized in the 16-bed Adult ICU at the university hospital in Istanbul, Turkey. The ICU was 3rd level ICU where medical and surgical patients received life support treatments and care at the highest level. The study was conducted between May 2020 and March 2021.
Who may be able to join
- The sample consisted of all patients
- over 18 years old
- who did not have pressure injuries upon admission to the intensive care unit. Patients who received norepinephrine and received norepinephrine infusion for at least 48 hours during their stay in ICU were included in the case group (n=149), and patients who did not receive an infusion were included in the control group (n=140).
Who cannot join
- The sample excluded of all patients
- less than 18
- who have pressure injuries during admission
- who had norepinephrine infusion less than48 hours during their stay in the intensive care unit.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Istanbul, 34010
About this study
Official title: The Determination of the Effect of Norepinephrine Infusion on the Development of Pressure Injury Among Critically Ill Patients
Norepinephrine mainly increases mean arterial pressure among intensive care patients. It may be an essential risk factor in developing pressure injuries. However, there are still conflicting findings in the literature.
This study aimed to examine the effect of norepinephrine infusion on the development of pressure injuries among patients in adult intensive care.
This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 289 adult patients (Case group n=149; control group n=149) treated with and without norepinephrine in the intensive care unit, respectively. The demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). A logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.
- Conditions
- Pressure Injury
- Keywords
- pressure injury, norepinephrine, vasopressor, intensive care, development
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Patients with norepinephrine infusion in the intensive care unit, | |
| Control group | Patients without norepinephrine in the intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of pressure injury after admission to intensive care unit until discharge
The development of pressure injuries after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. . This is a retrospective study, so there is no specific time. We specified time frame details below.
Measured: after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Dec 2024
- Primary completion31 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayda Kebapci, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860308
- Sponsor's protocol ID
- NR24022025
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data only can be shared during publication process with reviewer if necessary
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the Effect of Norepinephrine Infusion on the Development of Pressure Injury Among Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06860308
- Acronym / sponsor ID
- NR24022025
- Conditions
- Pressure Injury
- Keywords
- pressure injury, norepinephrine, vasopressor, intensive care, development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 6 Mar 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.
Norepinephrine mainly increases mean arterial pressure among intensive care patients. It may be an essential risk factor in developing pressure injuries. However, there are still conflicting findings in the literature.
This study aimed to examine the effect of norepinephrine infusion on the development of pressure injuries among patients in adult intensive care.
This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 289 adult patients (Case group n=149; control group n=149) treated with and without norepinephrine in the intensive care unit, respectively. The demographic and clinical characteristics were evaluated using descriptive statistical methods (number, percentage, mean, standard deviation). A logistic regression model was established to estimate the dependent variable (development of pressure injury) with the independent variables.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Patients with norepinephrine infusion in the intensive care unit, |
| Control group | – | –Patients without norepinephrine in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included all adult critically ill patients hospitalized in the 16-bed Adult ICU at the university hospital in Istanbul, Turkey. The ICU was 3rd level ICU where medical and surgical patients received life support treatments and care at the highest level. The study was conducted between May 2020 and March 2021.
Key inclusion criteria (3 listed)
- The sample consisted of all patients
- over 18 years old
- who did not have pressure injuries upon admission to the intensive care unit. Patients who received norepinephrine and received norepinephrine infusion for at least 48 hours during their stay in ICU were included in the case group (n=149), and patients who did not receive an infusion were included in the control group (n=140).
Key exclusion criteria (4 listed)
- The sample excluded of all patients
- less than 18
- who have pressure injuries during admission
- who had norepinephrine infusion less than48 hours during their stay in the intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
development of pressure injury after admission to intensive care unit until discharge
Time frame: after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. .
The development of pressure injuries after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. . This is a retrospective study, so there is no specific time. We specified time frame details below.
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 6 Mar 2025.
- Individual participant dataSharing planned: No. The data only can be shared during publication process with reviewer if necessary
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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?
An observational study of Pressure Injury, run by Koç 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 4 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 6 Mar 2025. 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?
development of pressure injury after admission to intensive care unit until discharge (time frame: after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. .). 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 6 Mar 2025.