SepsisFLAGS ( FLuidAndGender) (FLAGS)

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden, 11880
      • Södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Female gender
Male gender

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Type of fluids	Type according to Anatomical, Therapeutic and Chemical Classification System	First five days after admission.
Association between fluid therapy and levels of lactat	Analyze the whole cohort and female/ male gender as subgroups	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	First five days efter admission

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Sandra Jonmarker, Karolinska Institutet, Södersjukhuset

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Fluid Therapy; Gender difference
• Other Study ID Numbers: Sepsis-FluidsandGender

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No