Condition category
Circulatory System
Date applied
29/11/2005
Date assigned
10/03/2006
Last edited
02/05/2014
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

Mrs Maura Screaton

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P00785

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval

Ethics approval received from the local ethics committee on the 21/05/2002 (ref: H02/782).

Study design

Observational cohort study with an age and sex matched control population

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

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

http://www.papworthpeople.com/

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

Publication citations

Additional files

Editorial Notes