The Effect of Vasopressor on Pressure Injury Development

NCT06163352 | Completed

• 1 other identifier: PU
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasopressor Adverse Reaction; Pressure Injury; Pressure Ulcer

Keywords

vasopressor; pressure injury; pressure ulcer; development risk; prevention

Outcome Measures

Primary Outcomes (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.

  14 months

Study Arms (2)

Patients with pressure injury

EXPERIMENTAL

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

Patients without pressure injury

ACTIVE COMPARATOR

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

Interventions

Norepinephrine DRUG

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.

Also known as: dopamine

Patients with pressure injury; Patients without pressure injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koç University

Istanbul, None Selected, 34010, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 25662591 BACKGROUND

• 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.

  PMID: 22381988 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 27780589 BACKGROUND

• 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.

  PMID: 35791800 BACKGROUND

• 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.

  PMID: 19077028 BACKGROUND

• 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.

  PMID: 29923903 BACKGROUND

• 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.

  PMID: 27749790 BACKGROUND

• 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.

  PMID: 38479195 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Norepinephrine; Dopamine

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ayda Kebapci, Assoc Prof

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients with pressure injury (n=64) and patients without pressure injury (n=84)

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 8, 2023
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)