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Vasopressor Adverse ReactionNCT06163352

The Effect of Vasopressor on Pressure Injury Development

A study testing Norepinephrine in people with Vasopressor Adverse Reaction and Pressure Injury, run by Koç University 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

Background: Vasopressors are life-saving agents that increase mean arterial pressure. The pharmacodynamic features of these agents and previous studies suggest that vasopressors may be an essential risk factor in developing pressure injuries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Norepinephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2023to 1 Sep 2023
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

  • The sample consisted of all:
  • Medical and surgical patients over 18 who do not have pressure injury upon admission
  • Received one or more vasopressor agent infusions (norepinephrine, epinephrine, phenylephrine, dopamine, adrenaline, dobutamine) for at least 48 hours during their stay in the intensive care unit

Who cannot join

  • patients less than 18 years old
  • less than 48 hours stay in intensive care unit
  • did not receive ant vasospressor agents

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Koç University

    Istanbul, None Selected, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Vasopressor Agents on Pressure Injury Development in Intensive Care Patients

Background: Vasopressors are life-saving agents that increase mean arterial pressure. The pharmacodynamic features of these agents and previous studies suggest that vasopressors may be an essential risk factor in developing pressure injuries.

Objective: This study aimed to examine the effect of vasopressors in medical-surgical intensive care patients on pressure injury development.

Design and Settings: This retrospective and correlational study was conducted between March 2021- May 2022. The electronic patient data were obtained from 148 surgical and medical patients treated with vasopressor agents in the intensive care unit. Data on patients' 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.

Read the detailed description

There is a need for studies in which vasopressor drugs are discussed in detail and the risk factors that may cause pressure injury development in patients. Therefore, this study aims to examine vasopressors' effect on PI development among patients in intensive care units.

MATERIALS and METHODS Design This retrospective and correlational study examined the effect of vasopressors on pressure injury development in medical and surgical intensive care patients. The Consolidated Standards of Reporting Trials (CONSORT) statement guided this study (Boutron et al. , 2008) Ethics Approval The Ethics Committee of Koç University approved the study (2022.365.IRB1.155), and institutional permission was obtained.

Sample and Settings The study included all medical-surgical adult critical patients hospitalized in the 16-bed Adult Intensive Care Unit (ICU). It is a 3rd level ICU where medical and surgical patients receive life support treatments and care at the highest level. The study was conducted at XXX Hospital between May 2020 and March 2021. The study population consisted of 900 patients hospitalized in the ICU between these dates. The sample consisted of all medical and surgical patients over 18 who do not have pressure injury upon admission and received one or more vasopressor agent infusions (norepinephrine, epinephrine, phenylephrine, dopamine, adrenaline, dobutamine) for at least 48 hours during their stay in the ICU. Nurses checked skin and the existence of PI daily. They recorded their findings during the stay of the patients in the Pressure Wound Prevention Evaluation and Follow-up Form within 24 hours. Prevention, diagnosis, staging of pressure injury, and implementation of interventions appropriate to the stage were performed per this protocol. If pressure injury develops in patients, it is evaluated and staged, and appropriate interventions are decided for each patient under the leadership of the wound care nurse. After the first evaluation of the PI by the wound care nurse, the wound care nurse continued to evaluate patients' wounds daily. In line with all these approaches, it aimed to provide standardization for managing pressure injury prevention, staging, and implementation of interventions and to provide the highest reliability between nurses' evaluations and interventions. In line with this protocol, In the ICU, barrier cream or spray and gel adhesive dressings were used on the pressure areas of the body parts for prevention, and support skin surfaces were used to distribute the pressure by the pressure injury protocol.

Furthermore, skin hygiene and nourishing, applying gel adhesive dressing on pressure areas, repositioning of sedated patients every 2 hours, frequent position changes of unsedated patients, heel and head elevation, and nutritional assessment of patients were implemented to prevent PI. The European Pressure Ulcer Advisory Panel and the National Pressure Ulcer Advisory Panel Pressure Ulcers Classification System used by the nurses to stage the pressure injury of the accordingly Stage I (Nonblanchable erythema of intact skin), stage II (Partial-thickness skin loss with exposed dermis), stage III (Full-thickness skin loss), stage IV (Full-thickness skin and tissue loss), unstageable stage (Obscured full-thickness skin and tissue loss), and suspected deep tissue injury (Persistent nonblanchable deep red, maroon, or purple discoloration) (Edsberg, Black, 2016). All nurses working in the ICU attended the orientation training program before starting to work in the ICU and received formal training on pressure injury prevention, diagnosis, staging, and planning and implementation of appropriate interventions within the scope of this program.

Data Collection Data were obtained retrospectively from the electronic health record system by the researchers. The authors developed a data collection form to collect data. Data regarding the demographic characteristics included sex, age, and comorbid diseases. Clinical data included the diagnosis for ICU admission (medical/surgical), mechanical ventilation (MV) requirement and duration of MV, the total length of stay in ICU, the types of vasopressors used, the mean daily dose, and the duration of infusion of the vasopressor agents were recorded. The other PI risk factors (age>65, receiving chemotherapy, cachexia, being at the end of life, circulation problems, dehydration, and loss of sensation) were also determined. The data regarding the PI were obtained from the Pressure Wound Evaluation and Follow-up Form used by ICU nurses. Furthermore, the location, stage (based on the National Pressure Injury Advisory Panel staging system), and the time for PI development were between initiation of vasopressor vasopressor and pressure injury. In the case of PI development in patients, PI was staged under the leadership of the wound care nurse to provide standardization for pressure injury prevention, diagnosis staging, and the implementation of appropriate interventions in all patients.

Statistical Analysis Data was analyzed using SPSS (Statistical Package for Social Sciences) for Windows 28.0 program (IBM Corp.; Armonk, NY, USA). Data on patients' 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 PI) with the independent variables. The significance was evaluated at p<.05. Only statistically significant variables found at the 0.05 level were included in the model table; the statistically unsignificant variables were removed from the model, and the final model was decided. Using the logistic regression model and if the R2 value is 58.9%, the minimum number of samples was 97% at the 95% confidence 95% power level, and 5% standard error. Therefore, 148 participants were enough for regression analysis.

Being tested
Norepinephrine
Keywords
vasopressor, pressure injury, pressure ulcer, development risk, prevention
Medical subject headings
Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NorepinephrineDrug

    Also called dopamine

    The sample consisted of all medical and surgical patients over 18 who do not have pressure injury upon admission and received one or more vasopressor agent infusions (norepinephrine, epinephrine, dopamine) for at least 48 hours during their stay in the ICU and pressure injury development was assessed. The effect of combined use of more than one vasopressor agent on the development of pressure injury was investigated, considering the type and quantity of vasopressors (norepinephrine and dopamine), vasopressor combinations, total duration of infusion, and doses of vasopressors used.

Study groups in NCT06163352
Study groupRoleWhat they receive
Patients with pressure injuryExperimentalThe intervention is vasopressor infusion. In this am, 64 surgical and medical patients treated with vasopressor agents in the intensive care unit and developed pressure injury were included.
Receives: Drug: Norepinephrine
Patients without pressure injuryActive comparatorThe intervention is vasopressor infusion. In this arm, 84 surgical and medical patients treated with vasopressor agents in the intensive care unit and did not develop pressure injury were included.
Receives: Drug: Norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of pressure injury

    The development of the pressure injury was followed and the data regarding the PI were obtained from the Pressure Wound Evaluation and Follow-up Form.

    Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start1 May 2023
  3. Primary completion1 Aug 2023
  4. Study completion1 Sep 2023

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients with pressure injury (n=64) and patients without pressure injury (n=84)
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06163352
Sponsor's protocol ID
PU
Status last verified
Dec 2023
First submitted
14 Nov 2023
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tayyib N, Coyer F, Lewis P. Saudi Arabian adult intensive care unit pressure ulcer incidence and risk factors: a prospective cohort study. Int Wound J. 2016 Oct;13(5):912-9. doi: 10.1111/iwj.12406. Epub 2015 Feb 9.

    PubMed 25662591
  • Tschannen D, Bates O, Talsma A, Guo Y. Patient-specific and surgical characteristics in the development of pressure ulcers. Am J Crit Care. 2012 Mar;21(2):116-25. doi: 10.4037/ajcc2012716.

    PubMed 22381988
  • European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Injury Advisory Panel (NPUAP) and Pan Pacific Pressure Injury Alliance (2019). Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide. Emily Haesler (Ed.). https://static1.squarespace.com/static/6479484083027f25a6246fcb/t/647dc6c178b260694b5c9365/1685964483662/Quick_Reference_Guide-10Mar2019.pdf (accessed: 11/13/2023).

  • Lima Serrano M, Gonzalez Mendez MI, Carrasco Cebollero FM, Lima Rodriguez JS. Risk factors for pressure ulcer development in Intensive Care Units: A systematic review. Med Intensiva. 2017 Aug-Sep;41(6):339-346. doi: 10.1016/j.medin.2016.09.003. Epub 2016 Oct 22. English, Spanish.

    PubMed 27780589
  • Oczkowski S, Alshamsi F, Belley-Cote E, Centofanti JE, Hylander Moller M, Nunnaly ME, Alhazzani W. Surviving Sepsis Campaign Guidelines 2021: highlights for the practicing clinician. Pol Arch Intern Med. 2022 Aug 22;132(7-8):16290. doi: 10.20452/pamw.16290. Epub 2022 Jul 6.

    PubMed 35791800
  • Nijs N, Toppets A, Defloor T, Bernaerts K, Milisen K, Van Den Berghe G. Incidence and risk factors for pressure ulcers in the intensive care unit. J Clin Nurs. 2009 May;18(9):1258-66. doi: 10.1111/j.1365-2702.2008.02554.x. Epub 2008 Dec 11.

    PubMed 19077028
  • Cox J, Roche S, Murphy V. Pressure Injury Risk Factors in Critical Care Patients: A Descriptive Analysis. Adv Skin Wound Care. 2018 Jul;31(7):328-334. doi: 10.1097/01.ASW.0000534699.50162.4e.

    PubMed 29923903
  • Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.

    PubMed 27749790
  • Kebapci A, Tilki R. The effect of vasopressor agents on pressure injury development in intensive care patients. Intensive Crit Care Nurs. 2024 Aug;83:103630. doi: 10.1016/j.iccn.2024.103630. Epub 2024 Mar 12.

    PubMed 38479195

Questions about this trial

What is this clinical trial studying?

A study testing Norepinephrine in people with Vasopressor Adverse Reaction and 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 3 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 21 Dec 2023. 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 (time frame: 14 months). 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 NCT06163352, which also lists 9 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 21 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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