SepsisNCT04567433
Days Alive and Out of Hospital for Patients With Sepsis
An observational study of Sepsis and Septic Shock, run by The George Institute for Global Health, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Hydroxyethyl starch, Hydrocortisone and Early Goal Directed Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 6,213 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Sep 2020to 23 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have consented to enrolment into the ARISE, ADRENAL and CHEST trials
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Division of Critical Care, The George Institute for Global Health
Newtown, New South Wales, 2042
About this study
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.
Read the detailed description
Study Design
We will conduct a retrospective cohort study. After obtaining all required ethics approvals, we will obtain data from the ARISE, CHEST, and ADRENAL studies. We will obtain from each dataset, for each trial participant with sepsis, data regarding; Demographic details, co-morbidities, pre-morbid living situation, baseline severity of illness, receipt of and duration of organ support during the index hospitalisation, Duration of ICU stay during index hospitalisation, ICU mortality, Hospital length of stay (LOS) and mortality for index hospitalisation, Discharge destination from index hospitalisation, readmissions to hospital up to 2 years, long term mortality, and quality of life as measured by the EQ5D at longest follow-up.
The primary objective of the study is to assess the association between Days Alive and Out of Hospital at day 90 and longer-term quality of life as measured by the EQ5D.
Secondary objectives include:
- To describe the characteristics of DAOH90 in patients with sepsis and septic shock with respect to the distribution and the pattern of variability
- To assess the construct validity of DAOH90, by testing the association between baseline variables and process of care variables and DAOH90, with the hypothesis that indicators for more "sickness" will be associated with fewer DAOH
- Higher age
- Higher APACHE II
- Higher baseline lactate
- Higher SOFA score at baseline
- Premorbid accommodation in a long term care facility compared to independent living
- More co-morbidities at baseline
- Requirement for more organ support: requirement for 1, 2 or 3 (CVS, Resp, RRT) organ supports, and duration of organ support
- Participants with septic shock compared to sepsis
- Longer duration of admission for the index ICU admission
- Longer duration of hospital admission for the index hospitalisation
- To assess the extent to which DAOH90 captures long term mortality and resource use, by comparing the DAOH at day 90 to the DAOH at day 30, day 180 and day 365.
Sensitivity analysis For the primary analysis we will calculate the Days Alive and Out of Hospital with DAOH=0 for all patients who die prior to day 90, regardless of whether the death occurred in hospital or subsequent to discharge.
We will conduct a sensitivity analysis with Days Alive and Out of Hospital = the number of days alive and out of hospital prior to death. For example of a patient had a one week hospital admission and then spent 5 days at home prior to death the number of days alive and out of hospital = 5.
We will conduct a subgroup analysis based on:
- The group of trial participants who were admitted to the ICU directly from the Emergency Department compared to those admitted from the Operating Theatre or ward
- Sex
- Conditions
- Sepsis, Septic Shock
- Being tested
- Hydroxyethyl starch, Hydrocortisone, Early Goal Directed Therapy
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl starchDrug
Hydroxyethyl starch compared to 0.9% saline
HydrocortisoneDrug
Hydrocortisone compared to Placebo
Early Goal Directed TherapyProcedure or surgery
Early Goal Directed Therapy compared to Usual Care
| Study group | Role | What they receive |
|---|---|---|
| CHEST Study | Participants in the CHEST trial long term sepsis cohort Receives: Drug: Hydroxyethyl starch | |
| ARISE Study | Participants in the ARISE study long term follow-up cohort Receives: Procedure: Early Goal Directed Therapy | |
| ADRENAL study | Participants in the ADRENAL study Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life as measured by the EQ5D
Quality of Life as measured by the EQ5D
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start14 Sep 2020
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,213 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute for Global Health, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Delaney, The George Institute for Global Health, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567433
- Sponsor's protocol ID
- DAOHsepsis140920
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing would be considered by the respective management committees of the constituent trials on a case by case basis
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. doi: 10.1016/S1441-2772(23)00386-1.
PubMed 32900325Hammond 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.
PubMed 32676679Venkatesh 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.
PubMed 29347874Thompson 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.
PubMed 29951846Taylor 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.
PubMed 27324967Myburgh 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.
PubMed 23075127Higgins 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.
PubMed 30985391ARISE 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.
PubMed 25272316
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Days Alive and Out of Hospital for Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04567433
- Acronym / sponsor ID
- DAOHsepsis140920
- Conditions
- Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,213 participants (actual)
- Lead sponsor
- The George Institute for Global Health, AustraliaUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design
We will conduct a retrospective cohort study. After obtaining all required ethics approvals, we will obtain data from the ARISE, CHEST, and ADRENAL studies. We will obtain from each dataset, for each trial participant with sepsis, data regarding; Demographic details, co-morbidities, pre-morbid living situation, baseline severity of illness, receipt of and duration of organ support during the index hospitalisation, Duration of ICU stay during index hospitalisation, ICU mortality, Hospital length of stay (LOS) and mortality for index hospitalisation, Discharge destination from index hospitalisation, readmissions to hospital up to 2 years, long term mortality, and quality of life as measured by the EQ5D at longest follow-up.
The primary objective of the study is to assess the association between Days Alive and Out of Hospital at day 90 and longer-term quality of life as measured by the EQ5D.
Secondary objectives include:
- To describe the characteristics of DAOH90 in patients with sepsis and septic shock with respect to the distribution and the pattern of variability
- To assess the construct validity of DAOH90, by testing the association between baseline variables and process of care variables and DAOH90, with the hypothesis that indicators for more "sickness" will be associated with fewer DAOH
- Higher age
- Higher APACHE II
- Higher baseline lactate
- Higher SOFA score at baseline
- Premorbid accommodation in a long term care facility compared to independent living
- More co-morbidities at baseline
- Requirement for more organ support: requirement for 1, 2 or 3 (CVS, Resp, RRT) organ supports, and duration of organ support
- Participants with septic shock compared to sepsis
- Longer duration of admission for the index ICU admission
- Longer duration of hospital admission for the index hospitalisation
- To assess the extent to which DAOH90 captures long term mortality and resource use, by comparing the DAOH at day 90 to the DAOH at day 30, day 180 and day 365.
Sensitivity analysis For the primary analysis we will calculate the Days Alive and Out of Hospital with DAOH=0 for all patients who die prior to day 90, regardless of whether the death occurred in hospital or subsequent to discharge.
We will conduct a sensitivity analysis with Days Alive and Out of Hospital = the number of days alive and out of hospital prior to death. For example of a patient had a one week hospital admission and then spent 5 days at home prior to death the number of days alive and out of hospital = 5.
We will conduct a subgroup analysis based on:
- The group of trial participants who were admitted to the ICU directly from the Emergency Department compared to those admitted from the Operating Theatre or ward
- Sex
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHEST Study | – | Drug: Hydroxyethyl starchParticipants in the CHEST trial long term sepsis cohort |
| ARISE Study | – | Procedure: Early Goal Directed TherapyParticipants in the ARISE study long term follow-up cohort |
| ADRENAL study | – | Drug: HydrocortisoneParticipants in the ADRENAL study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have consented to enrolment into the ARISE, ADRENAL and CHEST trials
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl starchHydroxyethyl starch compared to 0.9% saline | Drug | CHEST Study |
| HydrocortisoneHydrocortisone compared to Placebo | Drug | ADRENAL study |
| Early Goal Directed TherapyEarly Goal Directed Therapy compared to Usual Care | Procedure or surgery | ARISE Study |
Primary outcome
Quality of Life as measured by the EQ5D
Time frame: 6 months
Quality of Life as measured by the EQ5D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 32900325Thompson 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. doi: 10.1016/S1441-2772(23)00386-1.
- Background: PubMed 32676679Hammond 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.
- Background: PubMed 29347874Venkatesh 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.
- Background: PubMed 29951846Thompson 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.
- Background: PubMed 27324967Taylor 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.
- Background: PubMed 23075127Myburgh 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.
- Background: PubMed 30985391Higgins 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.
- Background: PubMed 25272316ARISE 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.
- Individual participant dataSharing planned: Undecided. Data sharing would be considered by the respective management committees of the constituent trials on a case by case basis
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by The George Institute for Global Health, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life as measured by the EQ5D (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04567433, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.