SepsisFLAGS ( FLuidAndGender)

Sepsis Clinical Trial

— FLAGS  

Official title:

Fluid Treatment and the Impact of Gender in a Septic Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03811483
• Other study ID #: Sepsis-FluidsandGender
• Status: Not yet recruiting
• Start date: June 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2020
• Source: Karolinska Institutet
• Contact: Sandra Jonmarker
• Phone: +4686162238
• Email: sandra.jonmarker[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: June 1, 2021
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm	Stockholms Län

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gender differences in fluid treatment	Millilitres of fluid given per kilogram of patient weight (ml/kg).	Fluid therapy during the first six hours (adherence to sepsis bundles) and the first five days after admission.
Secondary	Association between amount of fluid and mortality	Analyze the whole cohort and female/ male gender as subgroups	In-Hospital Mortality, 30- and 90-days mortality
Secondary	Type of fluids	Type according to Anatomical, Therapeutic and Chemical Classification System	First five days after admission.
Secondary	Association between fluid therapy and levels of lactat	Analyze the whole cohort and female/ male gender as subgroups	First five days efter admission
Secondary	Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs	Analyze the whole cohort and female/ male gender as subgroups	First five days efter admission