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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04567433




Registration number
NCT04567433
Ethics application status
Date submitted
23/09/2020
Date registered
28/09/2020

Titles & IDs
Public title
Days Alive and Out of Hospital for Patients With Sepsis
Scientific title
Days Alive and Out of Hospital for Patients With Sepsis
Secondary ID [1] 0 0
DAOHsepsis140920
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Septic Shock 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Hydroxyethyl starch
Treatment: Drugs - Hydrocortisone
Treatment: Surgery - Early Goal Directed Therapy

CHEST Study - Participants in the CHEST trial long term sepsis cohort

ARISE Study - Participants in the ARISE study long term follow-up cohort

ADRENAL study - Participants in the ADRENAL study


Treatment: Drugs: Hydroxyethyl starch
Hydroxyethyl starch compared to 0.9% saline

Treatment: Drugs: Hydrocortisone
Hydrocortisone compared to Placebo

Treatment: Surgery: Early Goal Directed Therapy
Early Goal Directed Therapy compared to Usual Care
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quality of Life as measured by the EQ5D
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* We will include data from all participants in the ARISE and ADRENAL trials where there is data available to calculate the number of days alive and out of hospital to Day 90, and data available with regards to quality of life at 6 months following recruitment.
* We will include data from all participants in the CHEST trial who had a diagnosis of sepsis at baseline, and for whom there is data available to calculate the number of days alive and out of hospital to Day 90 and data available with regards to quality of life at 6 months following recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/02/2024
Sample size
Target
Accrual to date
Final
6213
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Division of Critical Care, The George Institute for Global Health - Newtown
Recruitment postcode(s) [1] 0 0
2042 - Newtown

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute for Global Health, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Data sharing would be considered by the respective management committees of the constituent trials on a case by case basis


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04567433