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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033653
• Other study ID #: sepsis long-term outcome
• Status: Completed
• Start date: November 2015
• Est. completion date: August 2018

Study information

• Verified date: July 2019
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1368
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Zhongda hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jianfeng Xie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year mortality	sepsis survivors will be followed up for 2-years	2 year
Primary	2-year readmission rate	sepsis survivors will be followed up for 2-years	2 year
Primary	mobility of sepsis survivors	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.	2 year
Primary	self-care of sepsis survivors	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.	2 year
Primary	usual activities of sepsis survivors	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.	2 year
Primary	discomfort or pain of sepsis survivors	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.	2 year
Primary	depression or anxiety of sepsis survivors	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.	2 year
Primary	the ability to judge and memory of sepsis survivors	It is scored by family or by yourself during telephone follow-up and is used to evaluate the quaity of life of sepsis survivors.	2 year
Secondary	influencing factors	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.	2 year