Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The anti-inflammatory properties of hydroxyethyl starches during abdominal aortic aneurysm surgery
Acronym
Study hypothesis
That hydroxyethyl starch with a mean molecular weight of 130 kDa (HES130/0.4) has better splanchnic perfusion and thus reduced inflammatory response compared with hydroxyethyl starch of mean molecular weight of 200 kDa (HES200/0.62).
Ethics approval
South Birmingham Ethics Committee, April 2001, ref: 5600
Study design
Single-centre unblinded randomised 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
Systemic inflammatory response during abdominal aortic aneurysm surgery.
Intervention
Blood volume expansion with either HES130/0.4, HES200/0.62 or gelatine.
This trial was carried out at Selly Oak Hospital, Birmingham, UK.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hydroxyethyl starch
Primary outcome measure
The following were assessed pre-operatively, at aortic clamping, reperfusion and then at regular time points after reperfusion (2, 4, 8, 12, 48 , 72, 96 and 120 hours):
Systemic inflammatory response:
1. Serum C-Reactive Protein (CRP)
2. White cell activation
3. Adhesion molecule expression
4. Endotoxin release
5. Splanchnic perfusion
Secondary outcome measures
The following were assessed pre-operatively, at aortic clamping, reperfusion and then at regular time points after reperfusion (2, 4, 8, 12, 48 , 72, 96 and 120 hours):
1. Renal dysfunction:
1.1. Urinary markers of renal injury
1.2. Serum urea and creatinine
2. Pulmonary dysfunction:
2.1. Lung injury score
Overall trial start date
01/04/2001
Overall trial end date
01/10/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients undergoing elective infra-renal abdominal aortic aneurysm repair using a transperitoneal route
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients with a history of allergy to any of the study solutions
2. Patients with a creatinine of greater than 177 mmol/L
3. Patients with significant iliac occlusive disease
Recruitment start date
01/04/2001
Recruitment end date
01/10/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Vascular Surgery
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Fresenius Kabi (Germany)
Sponsor details
Fluid Therapy Division
International Business Centre
Clinical Research
Homburg
61346-BAD
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fresenius Kabi (Germany)
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
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17380548
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19058981
Publication citations
-
Results
Mahmood A, Gosling P, Vohra RK, Randomized clinical trial comparing the effects on renal function of hydroxyethyl starch or gelatine during aortic aneurysm surgery., Br J Surg, 2007, 94, 4, 427-433, doi: 10.1002/bjs.5726.
-
Results
Mahmood A, Gosling P, Barclay R, Kilvington F, Vohra R, Splanchnic microcirculation protection by hydroxyethyl starches during abdominal aortic aneurysm surgery., Eur J Vasc Endovasc Surg, 2009, 37, 3, 319-325, doi: 10.1016/j.ejvs.2008.11.003.