Ascorbic Acid in open Abdominal Aortic Aneurysm repair

ISRCTN	ISRCTN27369400
DOI	https://doi.org/10.1186/ISRCTN27369400
Protocol serial number	RGHT000396
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Vascular Anaesthetic Society Great Britain & Ireland (VASGBI) (UK)

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

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

Study information

Primary study design	Interventional
Study design	Phase II single-centre prospective double-blind randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Ascorbic acid
Primary outcome measure(s)	Reduction in endothelial dysfunction as measured by plasma von Willebrand Factor (vWF) at fours hours post-removal of aortic cross clamp.
Key secondary outcome measure(s)	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
Completion date	01/08/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
Northern Ireland

Study participating centre

Royal Victoria Hospital

Belfast
BT12 6BA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes