SepsisNCT03789838

Effect of Sepsis Response Team in the Emergency Department

An observational study of Sepsis, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour? Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Sepsis rapid response team
How many people: 245 participants
Where: 1 siteNorway
Study dates: 15 May 2017to 15 May 2018
How long will I take part?: 1 Year
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: Adult patients with suspected sepsis in emergency department

Who may be able to join

Patients with suspected sepsis

Who cannot join

Patients who was consider not to need antibiotics

Trial locations and contacts

1 site in 1 country.

Norway1 site

Oslo University Hospital
Oslo, 0424

Other trials in Norway

About this study

Official title: Prospective Cohort Study Examining the Effect of a Sepsis Rapid Response Team in the Emergency Department

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour?

Read the detailed description

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour? The time from the patients arrive at the emergency department to an adequate antibiotic is given, before and after introduction of a sepsis response team, was registered.

Conditions: Sepsis
Being tested: Sepsis rapid response team
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sepsis rapid response teamOther
Patients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.

Study groups in NCT03789838
Study group	Role	What they receive
Before of sepsis rapid response team		Time from arrival at the Emergency Department to antibiotic is administered, before introduction of sepsis response team in the Emergency Department.
Sepsis rapid response team		Time from arrival at the Emergency Department to antibiotic is administered, with sepsis response team in the Emergency Department. Receives: Other: Sepsis rapid response team

What is being measured

The primary outcome is the main question the study is designed to answer.

Time from arrival the emergency department to antibiotic is given.
Time from arrival the emergency department to antibiotic is given.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201715 May 2018

First posted31 Dec 2018
Study start15 May 2017
Primary completion15 May 2018
Study completion15 May 2018

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 SepsisStudies of the same condition, open and under way.
More trials run by Oslo University HospitalThe sponsor's other registered studies.
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: Prospective
Enrolment: 245 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT03789838
Sponsor's protocol ID: Ulleval sepsis-01
Status last verified: Apr 2022
First submitted: 27 Dec 2018
Last updated: 3 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Trydal E, Martinsen AB, Beisland F, Jacobsen D, Holten AR. [Structured evaluation on arrival of patients with sepsis and initiation of antibiotics]. Tidsskr Nor Laegeforen. 2019 May 27;139(9). doi: 10.4045/tidsskr.18.0216. Print 2019 May 28. Norwegian.
PubMed 31140244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
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CT for Personalized Mechanical Ventilation
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RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Cohort Study Examining the Effect of a Sepsis Rapid Response Team in the Emergency Department
ClinicalTrials.gov ID: NCT03789838
Acronym / sponsor ID: Ulleval sepsis-01
Conditions: Sepsis
Study type: Observational
Recruitment status: Completed
Enrolment: 245 participants (actual)
Lead sponsor: Oslo University HospitalUniversity, hospital or other
Study start: 15 May 2017 (actual)
Primary completion: 15 May 2018 (actual)
Study completion: 15 May 2018 (actual)
First posted: 31 Dec 2018 (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.

Does sepsis response team in the emergency department increase the portion of sepsis patient who receive adequate treatment within one hour?

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 2

Arm	Type	Receives
Before of sepsis rapid response team	–	–Time from arrival at the Emergency Department to antibiotic is administered, before introduction of sepsis response team in the Emergency Department.
Sepsis rapid response team	–	Other: Sepsis rapid response teamTime from arrival at the Emergency Department to antibiotic is administered, with sepsis response team in the Emergency Department.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients with suspected sepsis in emergency department

Key inclusion criteria (1 listed)

Patients with suspected sepsis

Key exclusion criteria (1 listed)

Patients who was consider not to need antibiotics

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
Sepsis rapid response teamPatients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.	Other	Sepsis rapid response team

Primary outcome

Time from arrival the emergency department to antibiotic is given.
Time frame: 6 months
Time from arrival the emergency department to antibiotic is given.

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 3 May 2022.
Results publication: PubMed 31140244Trydal E, Martinsen AB, Beisland F, Jacobsen D, Holten AR. [Structured evaluation on arrival of patients with sepsis and initiation of antibiotics]. Tidsskr Nor Laegeforen. 2019 May 27;139(9). doi: 10.4045/tidsskr.18.0216. Print 2019 May 28. Norwegian.
Individual participant dataSharing planned: No

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

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.

Aleksander Holten, Phd, MD principal investigator

Oslo University Hospital

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 Sepsis, run by Oslo University Hospital at 1 site in Norway.

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 1 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 3 May 2022. 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 Norway. 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?

Time from arrival the emergency department to antibiotic is given. (time frame: 6 months). 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 NCT03789838, 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 3 May 2022.