Clinical trial NCT04033653: Long-term Quality of Life Among Survivors of Sepsis in China Assessed by EQ-5D
Official title: Long-term Outcome Among Survivors of Sepsis in China Assessed by EQ-5D
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 1368
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sepsis patients survived 90 days of oneset

Brief summary: Sepsis is a common critical illness in Intensive Care Unit (ICU). With the continuous progress of severe medicine, the mortality rate of ICU hospitalization for sepsis has decreased, but the long-term prognosis is not satisfied. Due to the high long-term mortality, poor physical and mental health and cognitive impairment, the long-term quality of life decreases greatly, putting great burden on the family and society. Therefore, it is of great significance to understand the epidemiology and risk factors of the long-term prognosis of sepsis and find out how to improve the prognosis .

Detailed description: Sepsis is a clinical syndrome in which the body's host response to uncontrolled infection leads to life-threatening organ dysfunction. In recent years, with the continuous improvement of the early diagnosis ability of sepsis, the deepening of the understanding of pathophysiology, and the continuous updating of treatment, the hospital mortality rate of sepsis has decreased significantly. However, studies have shown that the prevalence of sepsis is still increasing year by year, and the number of deaths due to sepsis is increasing. Sepsis is the main cause of death in ICU patients.

Although the mortality rate of patients with sepsis is significantly reduced, the increasing survival of patients with long-term outcome is not satisfied. All studies have shown that patients with sepsis have a high long-term mortality, and the long-term physiological, psychological, and cognitive function levels are reduced, which increases the economic burden and mental burden of the family and society. The increasing number of discharges has been considered a potential public health threat. In recent years, more and more researchers begin to pay attention to the long-term outcome of sepsis survivors. But compared with other acute or severe diseases, such as stroke, cancer, sepsis survivors has not been paid enough attention.

Therefore, all stages of treatment and rehabilitation of sepsis require extensive social attention. Continuous research and input are needed to explore predicting factors and effective interventions to improve the outcome and help patients and their families return to normal life,to reduce the social burden.

Eligibility criteria: Inclusion Criteria:

* survivors in the prior study (epidemiology survey of Chinese sepsis patients)

Exclusion Criteria:

* : patients who are unwilling to answer or lose their interviews

Primary outcomes:
measure: 2-year mortality
timeFrame: 2 year
measure: 2-year readmission rate
timeFrame: 2 year
measure: mobility of sepsis survivors
timeFrame: 2 year
measure: self-care of sepsis survivors
timeFrame: 2 year
measure: usual activities of sepsis survivors
timeFrame: 2 year
measure: discomfort or pain of sepsis survivors
timeFrame: 2 year
measure: depression or anxiety of sepsis survivors
timeFrame: 2 year
measure: the ability to judge and memory of sepsis survivors
timeFrame: 2 year
Secondary outcomes:
measure: influencing factors
timeFrame: 2 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Yang Yi, Ph.D.
role: STUDY_DIRECTOR
References: