Sepsis at Södersjukhuset-Adherence to Treatment Guidelines

Sepsis Clinical Trial

Official title:

Sepsis at Södersjukhuset-Adherence to Treatment Guidelines

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04055727
• Other study ID #: SepsisSoS
• Status: Active, not recruiting
• Start date: March 7, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective single-center study with patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Description:

In this single-center study, patients with suspected sepsis admitted to the Emergency Department at Södersjukhuset during a period of two years will be included. About 11,000 patients will be included. Patient data including described sepsis symptoms will be drawn from the electronic medical record, TakeCare and Clinisoft. Logistic regression analysis will adjust for age, gender, comorbidity according to Charlson score, vital signs, with preliminary focus of infection (pneumonia, urinary tract infection, abdominal, other, unknown). The Surviving Sepsis guidelines for the time period are: 3-hour bundle including lactate measurement, obtaining blood culture, fluid treatment if hypotensive and administration of broad-spectrum antibiotics. The 6-hour bundles with administration of vasopressors if needed, remeasure lactate if elevated, with persistent hypotension re-asses volume status and tissue perfusion. Time zero is defined as the admission time to the emergency department. The aim is to describe the association between adherence to treatment guidelines, gender, incidence and mortality for patients with sepsis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11000
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients admitted to the Emergency Department at Södersjukhuset with suspicion of sepsis defined as blood cultures taken and intravenous antibiotics of type beta-lactam or aminoglycoside prescribed within 48 hours of admission.

Exclusion criteria:

• Patients transferred from other hospitals or treatment clinics.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
Sweden	Södersjukhuset	Stockholm

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 90-day mortality	Gender differences in percentage of patients who died before day 90	90 days
Secondary	Association between adherence to treatment guidelines and mortality	Association between number of completed sepsis bundles and mortality	90 days
Secondary	Incidence of sepsis	Number of patients admitted to the Emergency Department at Södersjukhuset during the study period comparing to the hospitals catchment area	90 days