Restrictive versus standard fluid regime in patients undergoing elective infrarenal abdominal aortic aneurysm (AAA) repair

ISRCTN	ISRCTN27753612
DOI	https://doi.org/10.1186/ISRCTN27753612
Protocol serial number	RGHT 00372
Sponsor	Royal Victoria Hospital (UK)
Funder	Ulster Hospital Research Fellowship Committee (UK)

Submission date: 13/12/2006
Registration date: 31/03/2009
Last edited: 02/09/2009

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 Denis Harkin
Scientific

Royal Victoria Hospital
Grosvenor Road
Belfast
Bt12 6BA
United Kingdom

Study information

Primary study design	Interventional
Study design	Phase II single centre prospective randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Northern Ireland Ethics Committee gave approval on the 8th November 2006 (ref: 06/NIR02/110)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The difference in the number of patients with post-operative complications between the restrictive and standard treated groups.
Key secondary outcome measure(s)	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
Completion date	01/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	22
Key inclusion criteria	Adult patients (aged 18 years and over, either sex) admitted for elective open repair of AAA
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	01/11/2008

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Royal Victoria Hospital

Belfast
Bt12 6BA
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	01/07/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes