Condition category
Surgery
Date applied
26/01/2010
Date assigned
14/07/2010
Last edited
28/08/2014
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

Dr Ayesha Noorani

ORCID ID

Contact details

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

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 below 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 measures

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

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

Cambridge Vascular Unit
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

http://www.cuh.org.uk/research/

Funders

Funder type

Charity

Funder name

Addenbrookes Charitable Trust (UK) - Vascular Surgery Research Fund

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

Publication citations

Additional files

Editorial Notes