Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit

Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit - a Retrospective Study of Complications and Patient Outcomes

This is a single-center study retrospectively evaluating a local clinical routine to administer norepinephrine in midline catheters, with regard to complications and patient outcomes

Study Overview

• Status: Completed
• Conditions: Septic Shock; Hypotension and Shock; Norepinephrine Adverse Reaction
• Intervention / Treatment: Drug: Norepinephrine

Detailed Description

Se attached study protocol

• Study Type: Observational
• Enrollment (Actual): 473

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population are critically ill patients in need of vasopressors, primarily with septic shock.

Description

Inclusion Criteria:

• Administration of norepinephrine in a midline catheter in an intermediary care unit
• In Skåne university hospital
• From 2019 to 2023-03-31

Exclusion Criteria:

• Patients who have actively disabled review of their electronic medical record

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a major complication of norepinephrine administration in midline	extravasation of norepinephrine, midline-associated bloodstream infection, thrombosis	day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a minor complication of norepinephrine administration in midline	infiltration, occlusion of midline, dislodgement, leakage, other	day 30
Proportion of patients receiving a CVC after midline	Has the patient received central line after midline placement	day 30
Proportion of patients with different intermediary care unit outcomes	Where did the patient go after intermediary care? discharged / escalated to the ICU / deceased	day 30

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Gustav Torisson, PhD, Region Skåne

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: septic shock; norepinephrine; thrombosis; vasopressor; extravasation; midline catheter; catheter-related bloodstream infection
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: 2022-06476

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