Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/10/2010
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

Mr Joseph Alex

ORCID ID

Contact details

Cardiothoracic Surgery
Castle Hill Hospital
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084118514

Study information

Scientific title

Acronym

Study hypothesis

Does preoperative hyperoxia therapy reduce the serum levels of S100b protein, InterLeukin-6 (IL6), InterLeukin-8 (IL8), L-selectin, P-selectin, Inter-Cellular Adhesion Molecule 1 (ICAM-1), and improve neurological outcome in patients undergoing cardiopulmonary bypass?

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

Treatment

Patient information sheet

Condition

Cardiovascular: Cardiopulmonary bypass

Intervention

Randomised controlled trial comparing:
1. Hyperoxia therapy
2. No therapy

Study patients will receive the same intra-operative, postoperative and follow-up care as routine patients and as per unit protocol. A 30-day postoperative neuropsychological assessment will be undertaken. The patient will continue to receive routine postoperative follow-up care as per unit protocol.

The patients will undergo three sessions of hyperoxia therapy in the hyperbaric chamber situated at the BUPA Hospital, Anlaby Road, Hull. Each therapy consists of three 20-minute sessions in the hyperbaric chamber breathing 1005 O2 at 2.5 atmospheres interspread with five minutes of air breathing.

Blood samples will be taken for estimation of serum IL6, IL8, sE-selection, ICAM-1 and neutrophil CD18. This will be taken immediate pre-operation, at the end of the operation, 12 hours, 24 hours, 48 hours and fifth day post-operation. Blood samples for estimation of S100B will be taken immediate pre-operation, at the end of the operation, two hours and four hours after the operation.

A baseline neuropsychological test will be done within 24 h prior to the operation. The first postoperative assessment will be carried out when the performance is more stable, that is, three months postoperatively. To ensure objectivity and reliability of the assessment, the testing of each patient will be undertaken by the same doctor.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Data collected will be entered into the research department computer and statistical analysis will be done using the Stars Direct Package. Demographics, measures and results of data analysis will be represented as tables, graphs, bar charts and pie charts where applicable. Statistical significance will be set at P-value < 0.05.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/10/2002

Overall trial end date

15/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

A total of 50 patients (25 each group), between 20 and 75 years of age undergoing cardiopulmonary bypass.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

07/10/2002

Recruitment end date

15/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Surgery
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (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

1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16308008

Publication citations

  1. Results

    Alex J, Laden G, Cale AR, Bennett S, Flowers K, Madden L, Gardiner E, McCollum PT, Griffin SC, Pretreatment with hyperbaric oxygen and its effect on neuropsychometric dysfunction and systemic inflammatory response after cardiopulmonary bypass: a prospective randomized double-blind trial., J. Thorac. Cardiovasc. Surg., 2005, 130, 6, 1623-1630, doi: 10.1016/j.jtcvs.2005.08.018.

Additional files

Editorial Notes