Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03226912




Registration number
NCT03226912
Ethics application status
Date submitted
17/07/2017
Date registered
24/07/2017
Date last updated
15/09/2023

Titles & IDs
Public title
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Scientific title
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Secondary ID [1] 0 0
ANZIC-RC/CH002
Universal Trial Number (UTN)
Trial acronym
PREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Mechanical Ventilation Complication 0 0
Disabilities Multiple 0 0
Quality of Life 0 0
Physical Disability 0 0
Anxiety 0 0
Depression 0 0
Cognitive Change 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
Timepoint [1] 0 0
3-6 months post ICU admission
Secondary outcome [1] 0 0
Health related quality of life (HRQOL)
Timepoint [1] 0 0
3-6 months post ICU admission
Secondary outcome [2] 0 0
Pre ICU health status
Timepoint [2] 0 0
3 months post ICU admission
Secondary outcome [3] 0 0
Global function
Timepoint [3] 0 0
3-6 months post ICU admission
Secondary outcome [4] 0 0
Physical activity at 6 months
Timepoint [4] 0 0
6 months post ICU admission
Secondary outcome [5] 0 0
Cognitive function at 6 months
Timepoint [5] 0 0
6 months post ICU admission
Secondary outcome [6] 0 0
Anxiety and depression at 6 months will be assessed
Timepoint [6] 0 0
6 months post ICU admission
Secondary outcome [7] 0 0
Return to work at 3 and 6 months
Timepoint [7] 0 0
3-6 months post ICU admission
Secondary outcome [8] 0 0
Pre ICU disability and work status
Timepoint [8] 0 0
3 months post ICU admission

Eligibility
Key inclusion criteria
* ICU patients who have been mechanically ventilated for over 24 hours
* Patients 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* A Proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. TBI, SAH, stroke or hypoxic brain injury after cardiac arrest)
* Second or subsequent admission to ICU during a single hospital admission
* Participants who do not speak English

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Australian New Zealand Intensive Care Reseearch Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
As mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. In the US and UK, studies have been undertaken to assess the effects of specific long-term outcomes, such as functional disability and depression, which found long-term disabilities were much higher than baselines (pre-illness function) and ongoing at five years after ICU discharge. In order to improve quality of life of ICU survivors and ensure that medical specialists apply appropriate interventions to reduce the cost of these surviving patients on the community, the PREDICT management committee proposes the introduction of a patient-reported outcomes registry.
Trial website
https://clinicaltrials.gov/study/NCT03226912
Trial related presentations / publications
Higgins AM, Neto AS, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Hodgson CL; PREDICT Study Investigators. Predictors of death and new disability after critical illness: a multicentre prospective cohort study. Intensive Care Med. 2021 Jul;47(7):772-781. doi: 10.1007/s00134-021-06438-7. Epub 2021 Jun 5.
Hodgson CL, Higgins AM, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Iwashyna T, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Serpa Neto A; PREDICT Study Investigators. Comparison of 6-month outcomes of sepsis versus non-sepsis critically ill patients receiving mechanical ventilation. Crit Care. 2022 Jun 13;26(1):174. doi: 10.1186/s13054-022-04041-w.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03226912