Fluid restriction following open aortic aneurysm surgery
| ISRCTN | ISRCTN52446152 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52446152 |
| Protocol serial number | A091805 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Addenbrooke's Charitable Trust, Cambridge University Hospitals |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Cambridge Vascular Unit
Box 201
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
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 |
| Key secondary outcome measure(s) |
All measured as inpatient outcomes: |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
CB2 2QQ
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2017: No publications found, verifying study status with principal investigator.
