Skip to main content
Clinical Trials/NCT03811483
NCT03811483
Unknown
Not Applicable

Fluid Treatment and the Impact of Gender in a Septic Population

Karolinska Institutet1 site in 1 country5,000 target enrollmentJune 2020
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Karolinska Institutet
Enrollment
5000
Locations
1
Primary Endpoint
Gender differences in fluid treatment
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2020
End Date
June 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christer Svensen

Professor

Karolinska Institutet

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Type of fluids(First five days after admission.)
  • Association between fluid therapy and need for/ dose of vasopressors/inotropic drugs(First five days efter admission)
  • Association between fluid therapy and levels of lactat(First five days efter admission)
  • Association between amount of fluid and mortality(In-Hospital Mortality, 30- and 90-days mortality)

Study Sites (1)

Loading locations...

Similar Trials