Fluid restriction following open aortic aneurysm surgery

ISRCTN	ISRCTN52446152
DOI	https://doi.org/10.1186/ISRCTN52446152
Secondary identifying numbers	A091805

Submission date: 26/01/2010
Registration date: 14/07/2010
Last edited: 18/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ayesha Noorani
Scientific

Cambridge Vascular Unit
Box 201
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Study information

Study design	Single-centre randomised controlled trial
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 to request a patient information sheet
Scientific title	Does peri-operative fluid restriction affect renal function following major abdominal aortic surgery? A single-centre randomised controlled trial
Study acronym	PORAS
Study objectives	Fluid restriction following elective open infra-renal abdominal aortic surgery will affect biomarkers of renal impairment.
Ethics approval(s)	Cambridgeshire 3 Research Ethics Committee (REC), 08/01/2010, ref: 09/H0306/87
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2010
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key inclusion criteria	Elective patients (aged over 18 years, either sex) undergoing open infra-renal abdominal aortic aneurysm (AAA) repair
Key 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
Date of first enrolment	01/02/2010
Date of final enrolment	01/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
Box 277, Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/research/
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

Addenbrooke's Charitable Trust, Cambridge University Hospitals
Private sector organisation / Other non-profit organizations

Alternative name(s): Addenbrooke's Charitable Trust, Cambridge University Hospitals NHS Foundation Trust, ACT
Location: United Kingdom

Results and Publications

Intention to publish date
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

Editorial Notes

18/04/2017: No publications found, verifying study status with principal investigator.