NCT04033653

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

July 7, 2019

Last Update Submit

July 23, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • 2-year mortality

    sepsis survivors will be followed up for 2-years

    2 year

  • 2-year readmission rate

    sepsis survivors will be followed up for 2-years

    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.

    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.

    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.

    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.

    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.

    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.

    2 year

Secondary Outcomes (1)

  • influencing factors

    2 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

sepsis patients survived 90 days of oneset

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yang Yi, Ph.D.

    Zhongda Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending

Study Record Dates

First Submitted

July 7, 2019

First Posted

July 26, 2019

Study Start

November 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations