Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P00785
Study information
Scientific title
Do coronary artery bypass patients who stay in critical care have persisting psychological symptoms?
Acronym
Study hypothesis
Do coronary artery bypass patients who stay in critical care have persisting psychological symptoms?
Ethics approval
21/05/2002, ref: H02/782
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/08/2002
Overall trial end date
30/11/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/08/2002
Recruitment end date
30/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Critical Care
Cambridge
CB3 8RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
Papworth Hospital
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridgeshire Critical Care Network (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Papworth Hospital NHS Foundation Trust (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