Long-term Quality of Life Among Survivors of Sepsis in China Assessed by EQ-5D

Completed

• Conditions: Sepsis

• Registration Number: NCT04033653
• Lead Sponsor: Jianfeng Xie

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.

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1368

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year mortality	2 year	sepsis survivors will be followed up for 2-years
2-year readmission rate	2 year	sepsis survivors will be followed up for 2-years
depression or anxiety of sepsis survivors	2 year	one dimension of EQ-5D, which includes five dimensions and is used to evaluate the quaity of life of sepsis survivors. They are mobility， self-care，usual activities，discomfort or pain and depression or anxiety.
the ability to judge and memory of sepsis survivors	2 year	It is scored by family or by yourself during telephone follow-up and is used to evaluate the quaity of life of sepsis survivors.
mobility of sepsis survivors	2 year	one dimension of EQ-5D, which includes five dimensions and is used to evaluate the quaity of life of sepsis survivors. They are mobility， self-care，usual activities，discomfort or pain and depression or anxiety.
self-care of sepsis survivors	2 year	one dimension of EQ-5D, which includes five dimensions and is used to evaluate the quaity of life of sepsis survivors. They are mobility， self-care，usual activities，discomfort or pain and depression or anxiety.
discomfort or pain of sepsis survivors	2 year	one dimension of EQ-5D, which includes five dimensions and is used to evaluate the quaity of life of sepsis survivors. They are mobility， self-care，usual activities，discomfort or pain and depression or anxiety.
usual activities of sepsis survivors	2 year	one dimension of EQ-5D, which includes five dimensions and is used to evaluate the quaity of life of sepsis survivors. They are mobility， self-care，usual activities，discomfort or pain and depression or anxiety.

Secondary Outcome Measures

Name	Time	Method
influencing factors	2 year	explore the relationship between the outcome of sepsis survivors and clinical characteristics.The clinical characteristics is collected from Clinical case system,to explore their relationship with two-year survival, two-year quality of life of sepsis survivors.

Trial Locations

Locations (1)

Zhongda hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China