SepsisFLAGSNCT03811483
SepsisFLAGS ( FLuidAndGender)
An observational study of Sepsis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
In this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. About 11 000 patients will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 5,000 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2020to 1 Jun 2021
- 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 population is patients admitted at the emergency department at Södersjukhuset in Southern Stockholm. Södersjukhuset has 600 hospital beds and manages most medical fields except for highly specialized care for example neuro and thoracic surgery. 130 000 patients are seeking medical care yearly which makes the emergency department at Södersjukhuset the most frequented in Scandinavia.
Who may be able to join
- Patients admitted to the emergency department with suspected sepsis (defined by blood culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of 2 or more)
Who cannot join
- Patients transferred from other hospitals or treatment clinics.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Södersjukhuset
Stockholm, Stockholm County, 11880
Sandra Jonmarker, +4686162238 ext. +46709676710, sandra.jonmarker@sll.se
Maria Cronhjort, PhD, +4686162965 ext. +46735671555, maria.cronhjort@sll.se
About this study
Official title: Fluid Treatment and the Impact of Gender in a Septic Population
In this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. About 11 000 patients will be included. Patient data including fluid therapy will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic regression analysis, the investigators will adjust for age, gender, comorbidities, vital signs, preliminary focus of infection, level of care and renal replacement therapy. The aim is to analyze gender differences in fluid treatment and the response to fluid treatment and if the treatment is associated with differences in mortality.
- Conditions
- Sepsis
- Keywords
- Fluid Therapy, Gender difference
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female gender | Not described | |
| Male gender | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender differences in fluid treatment
Millilitres of fluid given per kilogram of patient weight (ml/kg).
Measured: Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.
Secondary outcomes (4)
Association between amount of fluid and mortality
Analyze the whole cohort and female/ male gender as subgroups
Measured: In-Hospital Mortality, 30- and 90-days mortality
Type of fluids
Type according to Anatomical, Therapeutic and Chemical Classification System
Measured: First five days after admission.
Association between fluid therapy and levels of lactat
Analyze the whole cohort and female/ male gender as subgroups
Measured: First five days efter admission
Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs
Analyze the whole cohort and female/ male gender as subgroups
Measured: First five days efter admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study startJun 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Sandra Jonmarker, Principal investigator, Karolinska Institutet, Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811483
- Sponsor's protocol ID
- Sepsis-FluidsandGender
- Acronym
- FLAGS
- Status last verified
- May 2020
- First submitted
- 11 Jan 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Treatment and the Impact of Gender in a Septic Population
- ClinicalTrials.gov ID
- NCT03811483
- Acronym / sponsor ID
- FLAGS / Sepsis-FluidsandGender
- Conditions
- Sepsis
- Keywords
- Fluid Therapy, Gender difference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 22 Jan 2019 (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.
In this single-center study the investigators will analyze gender differences among patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. About 11 000 patients will be included. Patient data including fluid therapy will be drawn from the electronic medical record; Take Care and Clinisoft. In the logistic regression analysis, the investigators will adjust for age, gender, comorbidities, vital signs, preliminary focus of infection, level of care and renal replacement therapy. The aim is to analyze gender differences in fluid treatment and the response to fluid treatment and if the treatment is associated with differences in mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female gender | – | – |
| Male gender | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population is patients admitted at the emergency department at Södersjukhuset in Southern Stockholm. Södersjukhuset has 600 hospital beds and manages most medical fields except for highly specialized care for example neuro and thoracic surgery. 130 000 patients are seeking medical care yearly which makes the emergency department at Södersjukhuset the most frequented in Scandinavia.
Key inclusion criteria (1 listed)
- Patients admitted to the emergency department with suspected sepsis (defined by blood culture taken and intravenous sepsis-antibiotics prescribed within 48 hours) and fulfilling sepsis-3 definition of sepsis (sequential organ failure assesment score of 2 or more)
Key exclusion criteria (1 listed)
- Patients transferred from other hospitals or treatment clinics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gender differences in fluid treatment
Time frame: Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.
Millilitres of fluid given per kilogram of patient weight (ml/kg).
4 secondary outcomes
Association between amount of fluid and mortality
Time frame: In-Hospital Mortality, 30- and 90-days mortality
Type of fluids
Time frame: First five days after admission.
Association between fluid therapy and levels of lactat
Time frame: First five days efter admission
Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs
Time frame: First five days efter admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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.
Sandra Jonmarker principal investigator
Karolinska Institutet, Södersjukhuset
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 Karolinska Institutet 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 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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Jonmarker (+4686162238 ext. +46709676710, sandra.jonmarker@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender differences in fluid treatment (time frame: Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.