Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A091805
Study information
Scientific title
Does peri-operative fluid restriction affect renal function following major abdominal aortic surgery? A single-centre randomised controlled trial
Acronym
PORAS
Study hypothesis
Fluid restriction following elective open infra-renal abdominal aortic surgery will affect biomarkers of renal impairment.
Ethics approval
Cambridgeshire 3 Research Ethics Committee (REC), 08/01/2010, ref: 09/H0306/87
Study design
Single-centre 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 to request a patient information sheet
Condition
Elective infra-renal aortic aneurysm surgery
Intervention
The intervention group will have a fluid-restricted regime of 1.5 l intravenous (IV) fluid per day post-operatively compared to 3 l in the standard regime group. Of course, there is provision for fluid resuscitation in the event that the patient requires this.
The total duration of treatment is 5 days and the follow-up is only inpatient.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Urinary levels of interleukin-18 (IL-18), neutrophil gelatinase-associate lipocalin (NGAL), retinol binding protein (RBP), albumin/creatinine ratio (ACR), measured at baseline (pre-operative), 6 hours, 12 hours, 24 hours, day 2 ,day 3, day 4, day 5
Secondary outcome measures
All measured as inpatient outcomes:
1. All major complications
2. Major adverse cardiac event (myocardial infarction, unstable angina, arrhythmia)
3. Respiratory complications (including need, duration and extent of ventilatory support)
4. Neurological complications (delirium, stroke)
5. Mortality
6. Length of stay
7. Intensive care unit (ITU)/high dependency unit (HDU) stay
8. Wound dehiscence
9. Gastrointestinal outcome measures:
9.1. Time to passage of first flatus
9.2. Time to passage of first faeces
9.3. Nausea scores
9.4. Time to resumption of normal diet
Overall trial start date
01/02/2010
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Elective patients (aged over 18 years, either sex) undergoing open infra-renal abdominal aortic aneurysm (AAA) repair
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Patients undergoing endovascular aortic aneurysm repair
2. Patients undergoing emergency surgery
3. Elective suprarenal AAA repair
4. Severe cardiac failure (New York Heart Association [NYHA] grade IV or myocardial infarction [MI] less than 3 months)
5. Pre-operative serum creatinine greater than 150 mg/dL
6. Pre-operative serum urea greater than 20 mmol/dl
7. Previous history of renal disease
8. Previous renal transplant
9. Patient scheduled to have simultaneous renal procedure at time of surgery
10. Established renal failure requiring renal replacement therapy
11. Previous history of hepatic disease
Recruitment start date
01/02/2010
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Box 277
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Addenbrooke's Charitable Trust, Cambridge University Hospitals
Alternative name(s)
Addenbrooke's Charitable Trust, Cambridge University Hospitals NHS Foundation Trust, ACT
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list