Condition category
Circulatory System
Date applied
13/12/2006
Date assigned
31/03/2009
Last edited
02/09/2009
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 Denis Harkin

ORCID ID

Contact details

Royal Victoria Hospital
Grosvenor Road
Belfast
Bt12 6BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT 00372

Study information

Scientific title

A prospective randomised clinical trial comparing a restrictive with a standard fluid regime in patients undergoing elective infrarenal abdominal aortic aneurysm (AAA) repair

Acronym

Study hypothesis

A restrictive fluid regime for elective open infra-renal abdominal aortic aneurysm (AAA) repair will improve clinical outcomes as judged primarily by a reduction in the number of patients with post-operative complications.

Ethics approval

Northern Ireland Ethics Committee gave approval on the 8th November 2006 (ref: 06/NIR02/110)

Study design

Phase II single centre prospective randomised controlled clinical 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

Abdominal aortic aneurysm

Intervention

In the standard regimen patients will be given standard fluid volume intra-operatively and post-operatively until day 5, consisting of 3 litres per day. However in the restricted group, less fluid will be given intra-operatively and only 2 litres per day until day 5.

Following discharge patients will be reviewed and examined at a vascular outpatient clinic at the 30-day, 3-month and 12-month post-operative stages.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

The difference in the number of patients with post-operative complications between the restrictive and standard treated groups.

Secondary outcome measures

1. Duration of hospital stay - recorded on discharge
2. Re-admission to Intensive Care Unit (ICU)/High Dependency Unit (HDU) and length of ICU/HDU stay - recorded following discharge from ICU
3. Oxygen saturation/fraction of inspired oxygen (FiO2):partial pressure of oxygen in arterial blood (PaO2) ratio - measured at baseline, and daily until day 5
4. Need for renal replacement therapy/estimated glomerular filtration rate (eGFR) - measured at baseline, and daily until day 5
5. First day of initial passage of flatus or faeces - recorded on occurrence
6. Differences in body weight - measured at baseline, and daily until day 5
7. Number of transfused platelet concentrates (PC)/fresh frozen plasma (FFP)/platelets - measured daily until day 5
8. Haematocrit - measured at baseline, and daily until day 5
9. Urinary albumin/creatinine ratio - measured at baseline, and daily until day 5
10. Sequential Organ Failure Assessment (SOFA) score - measured at baseline, and daily until day 5

Overall trial start date

01/01/2007

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients (aged 18 years and over, either sex) admitted for elective open repair of AAA

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

92 (recruitment ceased at 22 participants)

Participant exclusion criteria

1. Patients with established renal failure
2. Pre-operative haematological disorder
3. Known allergy to agents specified in the standardised anaesthetic protocol
4. Lack of consent
5. Participation in other trials within 30 days

Recruitment start date

01/01/2007

Recruitment end date

01/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Hospital
Belfast
Bt12 6BA
United Kingdom

Sponsor information

Organisation

Royal Victoria Hospital (UK)

Sponsor details

Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Ulster Hospital Research Fellowship Committee (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19561485

Publication citations

  1. Results

    McArdle GT, McAuley DF, McKinley A, Blair P, Hoper M, Harkin DW, Preliminary results of a prospective randomized trial of restrictive versus standard fluid regime in elective open abdominal aortic aneurysm repair., Ann. Surg., 2009, 250, 1, 28-34, doi: 10.1097/SLA.0b013e3181ad61c8.

Additional files

Editorial Notes