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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Fluid restriction following open aortic aneurysm surgery |
| ISRCTN | ISRCTN52446152 |
| ClinicalTrials.gov identifier | |
| Public title | Fluid restriction following open aortic aneurysm surgery |
| Scientific title | Does peri-operative fluid restriction affect renal function following major abdominal aortic surgery? A single centre randomised controlled trial |
| Acronym | PORAS study |
| Serial number at source | A091805 |
| Study hypothesis | Fluid restriction following elective open infra-renal abdominal aortic surgery will affect biomarkers of renal impairment. |
| Lay summary | |
| Ethics approval | Cambridgeshire 3 Research Ethics Committee (REC) approved on the 8th January 2010 (ref: 09/H0306/87) |
| Study design | Single centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Elective infra-renal aortic aneurysm surgery |
| Participants - inclusion criteria | Elective patients (aged over 18 years, either sex) undergoing open infra-renal abdominal aortic aneurysm (AAA) repair. |
| Participants - 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 mmols/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 |
| Anticipated start date | 01/02/2010 |
| Anticipated end date | 01/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 24 |
| Interventions |
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. |
| 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 |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Addenbrookes Charitable Trust (UK) - Vascular Surgery Research Fund |
| Trial website | |
| Publications | |
| Contact name | Dr Ayesha Noorani |
| Address |
Cambridge Vascular Unit
Box 201 Addenbrookes Hospital |
| City/town | Cambridge |
| Zip/Postcode | CB2 2QQ |
| Country | United Kingdom |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Address |
Research and Development Department
Box 277, Hills Road |
| City/town | Cambridge |
| Zip/Postcode | CB2 0QQ |
| Country | United Kingdom |
| Sponsor website: | http://www.cuh.org.uk/research/ |
| Date applied | 26/01/2010 |
| Last edited | 14/07/2010 |
| Date ISRCTN assigned | 14/07/2010 |
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