SepsisNCT04033653
Long-term Quality of Life Among Survivors of Sepsis in China Assessed by EQ-5D
An observational study of Sepsis, run by Jianfeng Xie at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- How many people
- 1,368 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: sepsis patients survived 90 days of oneset
Who may be able to join
- survivors in the prior study (epidemiology survey of Chinese sepsis patients)
Who cannot join
- : patients who are unwilling to answer or lose their interviews
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcome Among Survivors of Sepsis in China Assessed by EQ-5D
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 .
Read the 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.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year mortality
sepsis survivors will be followed up for 2-years
Measured: 2 year
2-year readmission rate
sepsis survivors will be followed up for 2-years
Measured: 2 year
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.
Measured: 2 year
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.
Measured: 2 year
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.
Measured: 2 year
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.
Measured: 2 year
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.
Measured: 2 year
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.
Measured: 2 year
Secondary outcomes (1)
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startNov 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jianfeng Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yang Yi, Ph.D., Study director, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033653
- Sponsor's protocol ID
- sepsis long-term outcome
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome Among Survivors of Sepsis in China Assessed by EQ-5D
- ClinicalTrials.gov ID
- NCT04033653
- Acronym / sponsor ID
- sepsis long-term outcome
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,368 participants (actual)
- Lead sponsor
- Jianfeng XieUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- sepsis patients survived 90 days of oneset
Key inclusion criteria (1 listed)
- survivors in the prior study (epidemiology survey of Chinese sepsis patients)
Key exclusion criteria (1 listed)
- : patients who are unwilling to answer or lose their interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2-year mortality
Time frame: 2 year
sepsis survivors will be followed up for 2-years
2-year readmission rate
Time frame: 2 year
sepsis survivors will be followed up for 2-years
mobility of sepsis survivors
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
depression or anxiety of sepsis survivors
Time frame: 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
Time frame: 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.
1 secondary outcome
influencing factors
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yi, Ph.D. study director
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Jianfeng Xie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year mortality (time frame: 2 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.