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CompletedNCT04033653Updated Jul 26, 2019

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

An observational study in Sepsis, sponsored by Jianfeng Xie. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2019-07-26.

Sponsored by Jianfeng Xie · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,368
Sex
All
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Study 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 .

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.

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Conditions studied

  • Sepsis

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03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's enrollment of 1,368 is above the median of 160 across 957 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Jianfeng Xie is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

sepsis patients survived 90 days of oneset

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • : patients who are unwilling to answer or lose their interviews
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,368 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 2-year mortality

    sepsis survivors will be followed up for 2-years

    Time frame: 2 year

  2. 2-year readmission rate

    sepsis survivors will be followed up for 2-years

    Time frame: 2 year

  3. 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.

    Time frame: 2 year

  4. 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.

    Time frame: 2 year

  5. 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.

    Time frame: 2 year

  6. 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.

    Time frame: 2 year

  7. 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.

    Time frame: 2 year

  8. 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.

    Time frame: 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.

    Time frame: 2 year

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Study locations

1 site
  • Zhongda hospital, Southeast University
    Nanjing, Jiangsu 210009, China
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2015 to primary completion in Aug 2018, 33 months.

Of 408 non-industry observational studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 33 months is close to that.

Counting every sponsor, half of 452 studies reached it within 29 months; a quarter within 12 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2019
First posted
Jul 26, 2019
StartActual
Nov 2015
Primary completionActual
Aug 2018
CompletionActual
Aug 2018
Last update
Jul 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04033653
Lead sponsor
Jianfeng Xie
Responsible party
Jianfeng Xie (Attending, Southeast University, China) — Sponsor-investigator
First posted
Jul 26, 2019
Start date
Nov 2015
Primary completion
Aug 2018
Completion
Aug 2018
Last update
Jul 26, 2019

Study contacts

Yang Yi, Ph.D.
study director · Zhongda Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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