Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04567433
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2020-09-23
Brief Title:
Days Alive and Out of Hospital for Patients With Sepsis
Sponsor:
The George Institute for Global Health Australia
Organization:
The George Institute for Global Health Australia
Study Overview
Official Title:
Days Alive and Out of Hospital for Patients With Sepsis
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 DAOH0 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
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 DAOH0 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None