Condition category
Circulatory System
Date applied
15/12/2007
Date assigned
14/02/2008
Last edited
28/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Rajiv Vohra

ORCID ID

Contact details

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

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 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):
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

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

http://www.fresenius-kabi.com

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

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17380548
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19058981

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes