Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000396
Study information
Scientific title
Non-invasive bed-side measurement of systemic endothelial function in patients undergoing abdominal aortic aneurysm repair: modulation by ascorbic acid
Acronym
AAAAA
Study hypothesis
In adult patients who undergo elective open abdominal aortic aneurysm (AAA) repair, intra-operative treatment with intravenous ascorbic acid improves endothelial function.
Ethics approval
Office for Research Ethics Committees Northern Ireland (ORECNI), 19/06/2007, ref: 07/NIR02/12
Study design
Phase II single-centre prospective double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Abdominal aortic aneurysm
Intervention
Participants will be randomised to either 2 g intravenous ascorbic acid or placebo (0.9% saline) infusion for intra-operative administration. Total duration of treatment is time taken to administer the infusion of the study drug: 20 minutes. All arms are followed up to hospital discharge.
Intervention type
Drug
Phase
Phase II
Drug names
Ascorbic acid
Primary outcome measures
Reduction in endothelial dysfunction as measured by plasma von Willebrand Factor (vWF) at fours hours post-removal of aortic cross clamp.
Secondary outcome measures
1. Systemic endothelial function as assessed by:
1.1. Adhesion molecules - soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble E-Selectin (sE-Selectin), measured pre-operatively and four hours post-removal aortic crossclamp
1.2. Urinary albumin:creatinine ratio (ACR), measured pre-operatively and four hours post-removal aortic crossclamp
1.3. Non-invasive assessment of endothelial function as determined by Pulse Wave Analysis, measured pre-operatively and four hours post-removal aortic crossclamp
2. Pulmonary endothelial dysfunction as measured by pulmonary dead space fraction, measured at post-intubation and pre-extubation approximately 1 hour post-cross clamp removal
3. Inflammatory response as measured by:
3.1. Highly sensitive C reactive protein (hsCRP), measured pre-operatively and four hours post-removal aortic crossclamp
3.2. Exhaled breath condensate pH, myeloperoxidase, and leukotriene B4, measured at post-intubation and pre-extubation approximately 1 hour post-cross clamp removal
4. Oxidative stress as measured by:
4.1. Serum lipid peroxides, measured pre-operatively and four hours post-removal aortic crossclamp
4.2. Urinary F2 isoprostanes, measured pre-operatively and four hours post-removal aortic crossclamp
4.3. Exhaled breath condensate hydrogen peroxide and 8-isoprostane, measured pre-operatively and four hours post-removal aortic crossclamp
Overall trial start date
01/01/2008
Overall trial end date
01/08/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients (aged 18 years or over, either sex) admitted for elective open repair of abdominal aortic aneurysm in the Royal Victoria Hospital.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
31
Participant exclusion criteria
1. Known history hyperoxaluria or glucose-6-phosphate dehydrogenase deficiency
2. Prior antioxidant therapy
3. Known allergy to ascorbic acid or agents specified in the standardised anaesthetic protocol
4. Lack of consent
Recruitment start date
01/01/2008
Recruitment end date
01/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Vascular Anaesthetic Society Great Britain & Ireland (VASGBI) (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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26215814