Do coronary artery bypass patients who stay in critical care have persisting psychological symptoms?

ISRCTN	ISRCTN34348429
DOI	https://doi.org/10.1186/ISRCTN34348429
Secondary identifying numbers	P00785

Submission date: 29/11/2005
Registration date: 10/03/2006
Last edited: 02/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Maura Screaton
Scientific

Critical Care
Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Do coronary artery bypass patients who stay in critical care have persisting psychological symptoms?
Study objectives	Do coronary artery bypass patients who stay in critical care have persisting psychological symptoms?
Ethics approval(s)	21/05/2002, ref: H02/782
Health condition(s) or problem(s) studied	Coronary artery disease
Intervention	Patients staying in critical care longer than 24 hours will be identified and approached for consent. An age and sex matched population staying in critical care for less than 24 hours will also be identified as the control group. Subjects will complete a patient satisfaction questionnaire prior to discharge. Questionnaires will be completed at 3, 6 and 12 months post-operatively to assess psychological symptoms (Hospital Anxiety and Depression [HAD], Trauma Symptom Checklist 33 [TSC-33], Experience after Treatment in Intensive Care 7-item scale [ETIC-7] and the SF-36 questionnaire)
Intervention type	Other
Primary outcome measure	The relationship between length of stay in critical care and psychological status.
Secondary outcome measures	The relationship between pre-operative Euroscore and length of stay in critical care.
Overall study start date	01/08/2002
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key inclusion criteria	1. Patients who are undergoing first-time coronary artery bypass grafting 2. All patients who are aged 18 and over 3. Patients who have stayed in critical care
Key exclusion criteria	1. Patients who have had any surgery other than coronary artery bypass grafting 2. Patients who have been admitted to critical care in the last year 3. Any patient who has a psychiatric disease, indicated by the use of anti-psychotics or admission to hospital 4. Patients with a neurological impairment 5. Patients who are unable to communicate
Date of first enrolment	01/08/2002
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Critical Care

Cambridge
CB3 8RE
United Kingdom

Sponsor information

Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
England
United Kingdom

Website	http://www.papworthpeople.com/
"ROR"	https://ror.org/01qbebb31

Funders

Funder type

Government

Cambridgeshire Critical Care Network (UK)

No information available

Papworth Hospital NHS Foundation Trust (UK)

No information available

Results and Publications

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

Editorial Notes

02/02/2017: No publications found in PubMed, verifying study status with principal investigator.