Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr Cipto Mangunkusumo General Hospital
About this trial
The goal of this observational study is to evaluate the effectiveness of implementing Koran Sepsis, or sepsis chart, a paper-based order set designed to guide the implementation of the One-hour Sepsis Bundle, in improving adherence to early sepsis management and reducing 7-day mortality among adult patients with sepsis presenting to the Emergency Department. The main questions it aims to answer are:
1. Does implementation of a sepsis chart improve adherence to the One-hour Sepsis Bundle among adult patients with sepsis? 2. Does implementation of a sepsis chart reduce 7-day mortality among adult patients with sepsis?
Researchers will compare the period before and after implementation of Koran Sepsis to determine whether its implementation improves adherence to the One-hour Sepsis Bundle and reduces 7-day mortality.
Participants will:
* Receive standard clinical care for sepsis, with management documented during the first hour after sepsis is suspected or diagnosed. * Receive care guided by sepsis chart after its implementation at the participating hospital. * Have clinical data collected from their medical records, including adherence to the One-hour Sepsis Bundle and time to administration of broad-spectrum antibiotics. * Be followed for seven days to determine their mortality outcome.
The study will include adult patients aged ≥18 years diagnosed with sepsis according to the Sepsis-3 definition who present to the Emergency Department and are admitted to one of two participating hospitals: Cipto Mangunkusumo and Fatmawati General Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged ≥18 years.
Patients diagnosed with sepsis according to the Sepsis-3 definition, using the lactate-modified qSOFA score as a reference.
Patients presenting to the Emergency Department.
Patients who are subsequently admitted to one of the participating hospitals: Cipto Mangunkusumo and Fatmawati General Hospital.
Disqualifiers
Incomplete clinical or outcome data required for the study analysis.
Trial population
Patients above ≥18 years diagnosed with sepsis in the emergency department in Cipto Mangunkusumo and Fatmawati General Hospital.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Sepsis chart (koran sepsis)
Other interventionImplementation of the sepsis one-hour bundle using a paper-based chart containing instructions for the recommended bundle components.
Usual care
Other interventionStandard sepsis management according to existing hospital practice without implementation of the study-specific sepsis one-hour bundle order set.
Treatment groups
304 Participants
are divided into 1 treatment groupGroup A: Sepsis patients2 interventions
Trial outcomes
Primary outcomes
1
All-cause mortality
All death attributed to any reason during study follow-up
Time frame
7 daysSecondary outcomes
1
Time to serum lactate measurement
Time to serum lactate measurement to identify adherence to the sepsis one-hour bundle, as documented using the paper-based order set containing instructions for the sepsis one-hour bundle.
Time frame
Within 1 hour after sepsis diagnosis2
Time to Administration of Broad-Spectrum Antibiotics
Time from sepsis diagnosis to administration of broad-spectrum antibiotics, based on documentation of patient management in the electronic health record (EHR) and sepsis record.
Time frame
Within 24 hours after study inclusion3
Time to blood culture collection
Time to blood culture collection to identify adherence to the sepsis one-hour bundle, as documented using the paper-based order set containing instructions for the sepsis one-hour bundle.
Time frame
Within 1 hour after sepsis diagnosis4
Time to administration of 30 mL/kg crystalloid fluid
Time to fluid administration to identify adherence to the sepsis one-hour bundle, as documented using the paper-based order set containing instructions for the sepsis one-hour bundle.
Time frame
Within 1 hour after sepsis diagnosisSponsors and contacts
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Source ClinicalTrials.gov