NCT06121115

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
473

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

October 3, 2023

Last Update Submit

March 11, 2024

Conditions

Keywords

vasopressornorepinephrineseptic shockmidline catheterthrombosisextravasationcatheter-related bloodstream infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with a major complication of norepinephrine administration in midline

    extravasation of norepinephrine, midline-associated bloodstream infection, thrombosis

    day 30

Secondary Outcomes (3)

  • Proportion of patients with a minor complication of norepinephrine administration in midline

    day 30

  • Proportion of patients receiving a CVC after midline

    day 30

  • Proportion of patients with different intermediary care unit outcomes

    day 30

Interventions

Norepinephrine administered in midline catheter according to clinical routine

Also known as: Vasopressors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (1)

  • Karlsson H, Afrasiabi A, Ohlsson M, Mansson V, Hartman H, Torisson G. Treating shock with norepinephrine administered in midline catheters in an intermediary care unit: a retrospective cohort study. BMJ Open. 2024 Dec 30;14(12):e091311. doi: 10.1136/bmjopen-2024-091311.

MeSH Terms

Conditions

Shock, SepticHypotensionShockThrombosis

Interventions

NorepinephrineVasoconstrictor Agents

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Gustav Torisson, PhD

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

November 7, 2023

Study Start

October 3, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations