The effect of intravenous fluids on abdominal aortic aneurysm surgery

ISRCTN	ISRCTN70166506
DOI	https://doi.org/10.1186/ISRCTN70166506
Protocol serial number	N/A
Sponsor	Fresenius Kabi (Germany)
Funder	Fresenius Kabi (Germany)

Submission date: 15/12/2007
Registration date: 14/02/2008
Last edited: 28/05/2014

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

Mr Rajiv Vohra
Scientific

Department of Vascular Surgery
University Hospital Birmingham NHS Trust
Selly Oak Hospital
Raddlebarn Road
Birmingham
B29 6JD
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre unblinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The anti-inflammatory properties of hydroxyethyl starches during abdominal aortic aneurysm surgery
Study objectives	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(s)	South Birmingham Ethics Committee, April 2001, ref: 5600
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydroxyethyl starch
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2002

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	60
Key inclusion criteria	All patients undergoing elective infra-renal abdominal aortic aneurysm repair using a transperitoneal route
Key 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
Date of first enrolment	01/04/2001
Date of final enrolment	01/10/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Vascular Surgery

Birmingham
B29 6JD
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	01/04/2007		Yes	No
Results article	results	01/03/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes