NCT03226912

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2.3 years

First QC Date

July 17, 2017

Last Update Submit

September 13, 2023

Conditions

Critical IllnessMechanical Ventilation ComplicationDisabilities MultipleQuality of LifePhysical DisabilityAnxietyDepressionCognitive Change

Outcome Measures

Primary Outcomes (1)

  • Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)

    Development of a risk-prediction model for disability-free survival in high risk patients (after \> 24 hours of mechanical ventilation)

    3-6 months post ICU admission

Secondary Outcomes (8)

  • Health related quality of life (HRQOL)

    3-6 months post ICU admission

  • Pre ICU health status

    3 months post ICU admission

  • Global function

    3-6 months post ICU admission

  • Physical activity at 6 months

    6 months post ICU admission

  • Cognitive function at 6 months

    6 months post ICU admission

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

500 critically ill patients who were mechanically ventilated \> 24 hours in an intensive care unit who have survived to hospital discharge.

You may qualify if:

  • ICU patients who have been mechanically ventilated for over 24 hours
  • Patients 18 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Australian New Zealand Intensive Care Reseearch Centre

Melbourne, Victoria, 3004, Australia

Location

Related Publications (2)

  • 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.

    PMID: 34089063RESULT

  • 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.

    PMID: 35698201DERIVED

MeSH Terms

Conditions

Critical IllnessAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 24, 2017

Study Start

July 18, 2017

Primary Completion

October 31, 2019

Study Completion

March 31, 2020

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

AU(1)