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SepsisFLAGS ( FLuidAndGender)

Fluid Treatment and the Impact of Gender in a Septic Population

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03811483
Acronym
FLAGS
Enrollment
5000
Registered
2019-01-22
Start date
2020-06-30
Completion date
2021-06-01
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Fluid Therapy, Gender difference

Brief 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. 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.

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Patients transferred from other hospitals or treatment clinics.

Design outcomes

Primary

MeasureTime frameDescription
Gender differences in fluid treatmentFluid 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).

Secondary

MeasureTime frameDescription
Association between amount of fluid and mortalityIn-Hospital Mortality, 30- and 90-days mortalityAnalyze the whole cohort and female/ male gender as subgroups
Type of fluidsFirst five days after admission.Type according to Anatomical, Therapeutic and Chemical Classification System
Association between fluid therapy and levels of lactatFirst five days efter admissionAnalyze the whole cohort and female/ male gender as subgroups
Association between fluid therapy and need for/ dose of vasopressors/inotropic drugsFirst five days efter admissionAnalyze the whole cohort and female/ male gender as subgroups

Countries

Sweden

Contacts

Primary ContactSandra Jonmarker
sandra.jonmarker@sll.se+4686162238
Backup ContactMaria Cronhjort, Ph D
maria.cronhjort@sll.se+4686162965

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026