Clinical trial NCT06163352: The Effect of Vasopressor on Pressure Injury Development
Official title: The Effect of Vasopressor Agents on Pressure Injury Development in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vasopressor Adverse Reaction
Pressure Injury
Pressure Ulcer
Keywords: vasopressor
pressure injury
pressure ulcer
development risk
prevention
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with pressure injury (n=64) and patients without pressure injury (n=84)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Development of pressure injury
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University
state: None Selected
Study officials:
affiliation: Koç University
name: Ayda Kebapci, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
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