Condition category
Not Applicable
Date applied
14/03/2006
Date assigned
02/05/2006
Last edited
07/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J Duncan Young

ORCID ID

Contact details

Intensive Care Society Trials Group
Kadoorie Centre
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 857626
duncan.young@nda.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 7.0

Study information

Scientific title

Acronym

ICON (Intensive Care Outcome Network) study

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.

As of 05/07/2011 the anticipated end date for this trial has been extended from 01/03/2009 to 28/03/2013.

Ethics approval

Oxford Research Ethics Committee B on 12/04/2006 (ref: 06/Q1605/17).

Study design

Prospective, longitudinal questionnaire-based study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Patients admitted to intensive care units

Intervention

Questionnaires regarding health-related quality of life (HRQOL).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2006

Overall trial end date

28/03/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

1,000 per year; total of 4,000

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Intensive Care Society Trials Group
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

The Intensive Care Society (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18559099

Publication citations

  1. Protocol

    Griffiths JA, Morgan K, Barber VS, Young JD, Study protocol: the Intensive Care Outcome Network ('ICON') study., BMC Health Serv Res, 2008, 8, 132, doi: 10.1186/1472-6963-8-132.

Additional files

Editorial Notes