Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
15/03/2016
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 R Ascione

ORCID ID

Contact details

c/o Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264149435

Study information

Scientific title

Neuro-endocrine and immuno-systems activation during coronary surgery

Acronym

Study hypothesis

To ascertain the effects of cardiopulmonary bypass (CPB) and cardioplegic arrest on the activation of the hypothalmic-pituatary-adrenal (HPA) system and on the relations between neuro endocrine and immune systems

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Coronary artery bypass grafting (CABG)

Intervention

Prospective randomised study patients randomised to:
1. With cardiopulmonary bypass
2. Without cardiopulmonary bypass

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To characterise the HPA system response during coronary surgery with or without cardiopulmonary bypass.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2004

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients admitted for first time coronary artery surgery suitable for on or off CPB surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant exclusion criteria

1. Single vessel coronary disease
2. Emergency referral
3. Previous Coronary Artery Graft Bypass (CAGB)
4. Evidence of severe thoracic disease

Recruitment start date

01/08/2004

Recruitment end date

31/07/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

15/03/2016: No publications found, verifying study status with principal investigator