Days Alive and Out of Hospital for Patients With Sepsis

February 22, 2024 updated by: Anthony Delaney, The George Institute for Global Health, Australia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newtown, New South Wales, Australia, 2042
        • Division of Critical Care, The George Institute for Global Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who have consented to enrolment into the ARISE, ADRENAL and CHEST trials

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CHEST Study
Participants in the CHEST trial long term sepsis cohort
Drug: Hydroxyethyl starch
Hydroxyethyl starch compared to 0.9% saline
ARISE Study
Participants in the ARISE study long term follow-up cohort
Procedure: Early Goal Directed Therapy
Early Goal Directed Therapy compared to Usual Care
ADRENAL study
Participants in the ADRENAL study
Drug: Hydrocortisone
Hydrocortisone compared to Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life as measured by the EQ5D
Time Frame: 6 months
Quality of Life as measured by the EQ5D
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The George Institute for Global Health, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

February 23, 2024

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAOHsepsis140920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing would be considered by the respective management committees of the constituent trials on a case by case basis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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