Implementation of a Sepsis Chart and Its Effects on Mortality Rate in Indonesian Primary Referral Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- All-cause mortality
研究概览
简要总结
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:
- Does implementation of a sepsis chart improve adherence to the One-hour Sepsis Bundle among adult patients with sepsis?
- 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.
详细描述
Background
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. If not recognized and treated promptly, sepsis may progress to septic shock, resulting in multiple organ failure and death. Sepsis is a serious complication of infectious diseases and remains one of the leading causes of death worldwide, particularly in low- and middle-income countries.
Globally, an estimated 48.9 million cases of sepsis occurred in 2017, with approximately 11 million sepsis-related deaths, accounting for 19.7% of all global deaths. Data from 16 Asian countries reported an intensive care unit mortality rate of 44.5% among patients with sepsis. At Dr. Cipto Mangunkusumo National Referral Hospital (RSCM), a 2017 study reported that 64% of adult patients with infection had sepsis, defined as a Sequential Organ Failure Assessment (SOFA) score >2. Another study conducted between 2016 and 2022 reported a mortality rate of 69% among patients with sepsis at RSCM, with a higher risk of mortality among patients with metabolic comorbidities. Data from the Community Services Coordinator of the Department of Internal Medicine at RSCM also showed that 10.3% of internal medicine inpatients were diagnosed with sepsis.
The One-hour Sepsis Bundle is a set of interventions recommended to be initiated within the first hour of suspected sepsis. These interventions include measurement of serum lactate, collection of blood cultures, administration of broad-spectrum antibiotics, fluid resuscitation, and hemodynamic management, with the aim of improving tissue perfusion and achieving early infection control.
Although several studies have demonstrated the effectiveness of the One-hour Sepsis Bundle in reducing mortality, its implementation at RSCM has not been systematically evaluated. Currently, there is no specific sepsis scoring system integrated into the Hospital Information System (HIS) or clinical pathway for patients with sepsis. In addition, a review by the Medical Committee indicated that the One-hour Sepsis Bundle had not been implemented in the majority of sepsis cases presenting to the Emergency Department (ED).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Incomplete clinical or outcome data required for the study analysis.
研究组 & 干预措施
Sepsis patients
All patients included in the study, diagnosed with sepsis according to the sepsis-3 criteria
干预措施: Sepsis chart (koran sepsis) (Other)
Sepsis patients
All patients included in the study, diagnosed with sepsis according to the sepsis-3 criteria
干预措施: Usual care (Other)
结局指标
主要结局
All-cause mortality
时间窗: 7 days
All death attributed to any reason during study follow-up
次要结局
- 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)
研究者
Robert Sinto
Principal Investigator
Dr Cipto Mangunkusumo General Hospital