Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals

NCT07843277 | Recruiting

• 1 other identifier: 26-04-0508
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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.

Conditions

Sepsis; Antimicrobial Resistance (AMR)

Keywords

sepsis; one-hour sepsis bundle

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All death attributed to any reason during study follow-up

  7 days

Secondary Outcomes (5)

• Time to serum lactate measurement

  Within 1 hour after sepsis diagnosis

• Time to Administration of Broad-Spectrum Antibiotics

  Within 24 hours after study inclusion

• Time to blood culture collection

  Within 1 hour after sepsis diagnosis

• Time to administration of 30 mL/kg crystalloid fluid

  Within 1 hour after sepsis diagnosis

• Vasopressor administration

  Within 24 hour after sepsis diagnosis

Study Arms (1)

Sepsis patients

All patients included in the study, diagnosed with sepsis according to the sepsis-3 criteria

Other: Sepsis chart (koran sepsis); Other: Usual care

Interventions

Sepsis chart (koran sepsis) OTHER

Implementation of the sepsis one-hour bundle using a paper-based chart containing instructions for the recommended bundle components.

Sepsis patients

Usual care OTHER

Standard sepsis management according to existing hospital practice without implementation of the study-specific sepsis one-hour bundle order set.

Sepsis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients above ≥18 years diagnosed with sepsis in the emergency department in Cipto Mangunkusumo and Fatmawati General Hospital.

You may qualify if:

• 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.

You may not qualify if:

• Incomplete clinical or outcome data required for the study analysis.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (2)

Dr Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Fatmawati General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sharifah Shakinah, MD

CONTACT

+628129670607; sharifah.shakinah@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

ID (2)