Ascorbic Acid in open Abdominal Aortic Aneurysm repair
| ISRCTN | ISRCTN27369400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27369400 |
| Secondary identifying numbers | RGHT000396 |
- Submission date
- 16/10/2008
- Registration date
- 12/11/2008
- Last edited
- 29/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Danny McAuley
Scientific
Scientific
Regional Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Phase II single-centre prospective double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Non-invasive bed-side measurement of systemic endothelial function in patients undergoing abdominal aortic aneurysm repair: modulation by ascorbic acid |
| Study acronym | AAAAA |
| Study objectives | In adult patients who undergo elective open abdominal aortic aneurysm (AAA) repair, intra-operative treatment with intravenous ascorbic acid improves endothelial function. |
| Ethics approval(s) | Office for Research Ethics Committees Northern Ireland (ORECNI), 19/06/2007, ref: 07/NIR02/12 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Ascorbic acid |
| Primary outcome measure | 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 study start date | 01/01/2008 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 31 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
| Website | http://www.qub.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/02tdmfk69 |
Funders
Funder type
Research organisation
Vascular Anaesthetic Society Great Britain & Ireland (VASGBI) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2015 | Yes | No |
