The effect of intravenous fluids on abdominal aortic aneurysm surgery
ISRCTN | ISRCTN70166506 |
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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
Scientific
Department of Vascular Surgery
University Hospital Birmingham NHS Trust
Selly Oak Hospital
Raddlebarn Road
Birmingham
B29 6JD
United Kingdom
Study information
Study design | Single-centre unblinded randomised controlled trial |
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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 | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2001 |
Completion date | 01/10/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Sponsor information
Fresenius Kabi (Germany)
Industry
Industry
Fluid Therapy Division
International Business Centre
Clinical Research
Homburg
61346-BAD
Germany
Website | http://www.fresenius-kabi.com |
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https://ror.org/01v376g59 |
Funders
Funder type
Industry
Fresenius Kabi (Germany)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/04/2007 | Yes | No | |
Results article | results | 01/03/2009 | Yes | No |