SepsisFLAGS ( FLuidAndGender)

• Conditions: Sepsis

• Registration Number: NCT03811483
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27
• Study Start: 2020-06
• Primary Completion: 2020-08-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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)

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Exclusion Criteria

• Patients transferred from other hospitals or treatment clinics.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gender differences in fluid treatment	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).

Secondary Outcome Measures

Name	Time	Method
Type of fluids	First five days after admission.	Type according to Anatomical, Therapeutic and Chemical Classification System
Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs	First five days efter admission	Analyze the whole cohort and female/ male gender as subgroups
Association between fluid therapy and levels of lactat	First five days efter admission	Analyze the whole cohort and female/ male gender as subgroups
Association between amount of fluid and mortality	In-Hospital Mortality, 30- and 90-days mortality	Analyze the whole cohort and female/ male gender as subgroups

Trial Locations

Locations (1)

Södersjukhuset; 🇸🇪 Stockholm, Stockholms Län, Sweden