Septic ShockNCT06121115
Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit
An observational study of Septic Shock and Norepinephrine Adverse Reaction, run by Region Skane at 1 site in Sweden.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Norepinephrine Adverse Reaction, Hypotension and Shock
- What is being tested?
- Norepinephrine
- How many people
- 473 participants
- Where
- 1 siteSweden
- Study dates
- 3 Oct 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are critically ill patients in need of vasopressors, primarily with septic shock.
Who may be able to join
- Administration of norepinephrine in a midline catheter in an intermediary care unit
- In Skåne university hospital
- From 2019 to 2023-03-31
Who cannot join
- Patients who have actively disabled review of their electronic medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
Se attached study protocol
- Being tested
- Norepinephrine
- Keywords
- vasopressor, norepinephrine, septic shock, midline catheter, thrombosis, extravasation, catheter-related bloodstream infection
- Medical subject headings
- Shock, Septic, Hypotension, Shock, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Vasopressors
Norepinephrine administered in midline catheter according to clinical routine
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a major complication of norepinephrine administration in midline
extravasation of norepinephrine, midline-associated bloodstream infection, thrombosis
Measured: day 30
Secondary outcomes (3)
Proportion of patients with a minor complication of norepinephrine administration in midline
infiltration, occlusion of midline, dislodgement, leakage, other
Measured: day 30
Proportion of patients receiving a CVC after midline
Has the patient received central line after midline placement
Measured: 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
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start3 Oct 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustav Torisson, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121115
- Sponsor's protocol ID
- 2022-06476
- Status last verified
- Mar 2024
- First submitted
- 3 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39806688
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit - a Retrospective Study of Complications and Patient Outcomes
- ClinicalTrials.gov ID
- NCT06121115
- Acronym / sponsor ID
- 2022-06476
- Keywords
- vasopressor, norepinephrine, septic shock, midline catheter, thrombosis, extravasation, catheter-related bloodstream infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Se attached study protocol
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are critically ill patients in need of vasopressors, primarily with septic shock.
Key inclusion criteria (3 listed)
- Administration of norepinephrine in a midline catheter in an intermediary care unit
- In Skåne university hospital
- From 2019 to 2023-03-31
Key exclusion criteria (1 listed)
- Patients who have actively disabled review of their electronic medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineAlso: VasopressorsNorepinephrine administered in midline catheter according to clinical routine | Drug | – |
Primary outcome
Proportion of patients with a major complication of norepinephrine administration in midline
Time frame: day 30
extravasation of norepinephrine, midline-associated bloodstream infection, thrombosis
3 secondary outcomes
Proportion of patients with a minor complication of norepinephrine administration in midline
Time frame: day 30
Proportion of patients receiving a CVC after midline
Time frame: day 30
Proportion of patients with different intermediary care unit outcomes
Time frame: day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 39806688Karlsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav Torisson, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Norepinephrine Adverse Reaction, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a major complication of norepinephrine administration in midline (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.