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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16308008
Publication citations
-
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.