The Effect of Vasopressor on Pressure Injury Development

December 14, 2023 updated by: Ayda Kebapci, Koç University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • None Selected
      • Istanbul, None Selected, Turkey, 34010
        • Koc University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pressure injury
The 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.
Drug: Norepinephrine
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.
Other Names:
  • dopamine
Active Comparator: Patients without pressure injury
The 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.
Drug: Norepinephrine
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.
Other Names:
  • dopamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of pressure injury
Time Frame: 14 months
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.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Principal Investigator: Ayda Kebapci, Assoc Prof, Koc University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pressure Ulcer

Clinical Trials on Norepinephrine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe