Intensive care unit outcome study

ISRCTN	ISRCTN69112866
DOI	https://doi.org/10.1186/ISRCTN69112866
Secondary identifying numbers	Version 7.0

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr J Duncan Young
Scientific

Intensive Care Society Trials Group
Kadoorie Centre
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 857626
Email	duncan.young@nda.ox.ac.uk

Study design	Prospective longitudinal questionnaire-based study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Intensive care unit outcome study
Study acronym	ICON (Intensive Care Outcome Network)
Study hypothesis	The primary purpose of the study is to generate a register of patients discharged from intensive care units (ICUs). The registry will be used to study ICU treatment and its relation to mortality and long-term psychological morbidity, as well as changes in health-related quality of life over time after discharge from ICU.
Ethics approval(s)	Oxford Research Ethics Committee B, 12/04/2006, ref: 06/Q1605/17
Condition	Patients admitted to intensive care units
Intervention	Questionnaires regarding health-related quality of life (HRQOL).
Intervention type	Other
Primary outcome measure	To start and maintain a register of patients discharged from hospital after being treated for greater than 24 hours in a participating ICU.
Secondary outcome measures	To evaluate in survivors of intensive care treatment: 1. Health-related quality of life 2. Risk of post-traumatic stress disorder (PTSD) 3. Major depression and anxiety incidence 4. Quality-adjusted life-years (QALYs)
Overall study start date	01/03/2006
Overall study end date	28/03/2013

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1,000 per year; total of 4,000
Participant inclusion criteria	1. All patients that survive to discharge from a participating ICU and remained on the ICU for greater than 24 hours 2. Patients aged 16 years or older on date of ICU admission
Participant exclusion criteria	1. Patients in non-participating ICUs 2. Patients admitted to a participating ICU who stayed less than 24 hours 3. Patients that do not survive to ICU discharge 4. Patients who are under 16 years old on date of ICU admission 5. Patients readmitted to an ICU and already entered in the ICON study will not have their new admission recorded
Recruitment start date	01/03/2006
Recruitment end date	28/03/2013

John Radcliffe Hospital

Oxford
OX3 9DU
United Kingdom

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Office
Manor House
Headley Way
Oxford
OX3 9DZ
England
United Kingdom

"ROR"	https://ror.org/03h2bh287

Research organisation

Intensive Care Society
Private sector organisation / Associations and societies (private and public)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/06/2008		Yes	No
Results article	results	27/03/2017		Yes	No

30/03/2017: Publication reference added.
05/07/2011: The overall trial end date was changed from 01/03/2009 to 28/03/2013.