NCT06860308

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 25, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

pressure injurynorepinephrinevasopressorintensive caredevelopment

Outcome Measures

Primary Outcomes (1)

  • 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.

    after admission of patients to the intensive care unit until discharge between from March 2021 to May 2022. .

Study Arms (2)

Case Group

Patients with norepinephrine infusion in the intensive care unit,

Control group

Patients without norepinephrine in the intensive care unit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koç University Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 6, 2025

Study Start

December 1, 2024

Primary Completion

January 31, 2025

Study Completion

February 20, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The data only can be shared during publication process with reviewer if necessary

Locations