Condition category
Circulatory System
Date applied
16/10/2008
Date assigned
12/11/2008
Last edited
29/07/2015
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 Danny McAuley

ORCID ID

Contact details

Regional Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

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

http://www.qub.ac.uk/

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

Publication citations

Additional files

Editorial Notes