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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04567433
Ethics application status
Date submitted
23/09/2020
Date registered
28/09/2020
Date last updated
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 - 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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
We will perform a retrospective cohort study to assess the construct validity and performance
of days alive and out of hospital at day 90 (DAOH90) in cohorts of patients with sepsis and
septic shock who have been included in recent clinical trials.
Trial website
https://clinicaltrials.gov/show/NCT04567433
Trial related presentations / publications
Thompson KJ, Taylor CB, Venkatesh B, Cohen J, Hammond NE, Jan S, Li Q, Myburgh J, Rajbhandari D, Saxena M, Kumar A, Finfer SR; The ADRENAL Management Committee and Investigators and the ANZICS Clinical Trials Group . The cost-effectiveness of adjunctive corticosteroids for patients with septic shock. Crit Care Resusc. 2020 Sep;22(3):191-199.
Hammond NE, Finfer SR, Li Q, Taylor C, Cohen J, Arabi Y, Bellomo R, Billot L, Harward M, Joyce C, McArthur C, Myburgh J, Perner A, Rajbhandari D, Rhodes A, Thompson K, Webb S, Venkatesh B; ADRENAL Trial Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Health-related quality of life in survivors of septic shock: 6-month follow-up from the ADRENAL trial. Intensive Care Med. 2020 Sep;46(9):1696-1706. doi: 10.1007/s00134-020-06169-1. Epub 2020 Jul 16.
Venkatesh B, Finfer S, Cohen J, Rajbhandari D, Arabi Y, Bellomo R, Billot L, Correa M, Glass P, Harward M, Joyce C, Li Q, McArthur C, Perner A, Rhodes A, Thompson K, Webb S, Myburgh J; ADRENAL Trial Investigators and the Australian-New Zealand Intensive Care Society Clinical Trials Group. Adjunctive Glucocorticoid Therapy in Patients with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):797-808. doi: 10.1056/NEJMoa1705835. Epub 2018 Jan 19.
Thompson K, Taylor C, Jan S, Li Q, Hammond N, Myburgh J, Saxena M, Venkatesh B, Finfer S. Health-related outcomes of critically ill patients with and without sepsis. Intensive Care Med. 2018 Aug;44(8):1249-1257. doi: 10.1007/s00134-018-5274-x. Epub 2018 Jun 27.
Taylor C, Thompson K, Finfer S, Higgins A, Jan S, Li Q, Liu B, Myburgh J; Crystalloid versus Hydroxyethyl Starch Trial (CHEST) investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Hydroxyethyl starch versus saline for resuscitation of patients in intensive care: long-term outcomes and cost-effectiveness analysis of a cohort from CHEST. Lancet Respir Med. 2016 Oct;4(10):818-825. doi: 10.1016/S2213-2600(16)30120-5. Epub 2016 Jun 17.
Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SA; CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med. 2012 Nov 15;367(20):1901-11. doi: 10.1056/NEJMoa1209759. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2016 Mar 31;374(13):1298.
Higgins AM, Peake SL, Bellomo R, Cooper DJ, Delaney A, Harris AH, Howe BD, Nichol AD, Webb SA, Williams PJ; Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group. Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial. Crit Care Med. 2019 Jun;47(6):765-773. doi: 10.1097/CCM.0000000000003762.
ARISE Investigators; ANZICS Clinical Trials Group, Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
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

Summary results
Other publications