The effect of intravenous fluids on abdominal aortic aneurysm surgery

ISRCTN ISRCTN70166506
DOI https://doi.org/10.1186/ISRCTN70166506
Secondary identifying numbers N/A
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

Study designSingle-centre unblinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe anti-inflammatory properties of hydroxyethyl starches during abdominal aortic aneurysm surgery
Study objectivesThat 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) studiedSystemic inflammatory response during abdominal aortic aneurysm surgery.
InterventionBlood volume expansion with either HES130/0.4, HES200/0.62 or gelatine.

This trial was carried out at Selly Oak Hospital, Birmingham, UK.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Hydroxyethyl starch
Primary outcome measureThe 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 measuresThe 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 study start date01/04/2001
Completion date01/10/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants60
Key inclusion criteriaAll patients undergoing elective infra-renal abdominal aortic aneurysm repair using a transperitoneal route
Key exclusion criteria1. 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 enrolment01/04/2001
Date of final enrolment01/10/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Vascular Surgery
Birmingham
B29 6JD
United Kingdom

Sponsor information

Fresenius Kabi (Germany)
Industry

Fluid Therapy Division
International Business Centre
Clinical Research
Homburg
61346-BAD
Germany

Website http://www.fresenius-kabi.com
ROR logo "ROR" https://ror.org/01v376g59

Funders

Funder type

Industry

Fresenius Kabi (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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