- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04033653
Long-term Quality of Life Among Survivors of Sepsis in China Assessed by EQ-5D
Long-term Outcome Among Survivors of Sepsis in China Assessed by EQ-5D
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210009
- Zhongda Hospital, Southeast University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2-year mortality
Time Frame: 2 year
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sepsis survivors will be followed up for 2-years
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2 year
|
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2-year readmission rate
Time Frame: 2 year
|
sepsis survivors will be followed up for 2-years
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2 year
|
|
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.
|
2 year
|
|
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.
|
2 year
|
|
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.
|
2 year
|
|
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.
|
2 year
|
|
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.
|
2 year
|
|
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.
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2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
influencing factors
Time Frame: 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.
|
2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yang Yi, Ph.D., Zhongda Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sepsis long-term outcome
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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The University of QueenslandRoyal Brisbane and Women's HospitalUnknown
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Ohio State UniversityCompletedSepsis, Severe Sepsis and Septic ShockUnited States
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
Rennes University HospitalUnknownSevere Sepsis or Septic Shock
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityEnrolling by invitationSevere Sepsis | Severe Sepsis Without Septic ShockUnited States