Restrictive versus standard fluid regime in patients undergoing elective infrarenal abdominal aortic aneurysm (AAA) repair
| ISRCTN | ISRCTN27753612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27753612 |
| Secondary identifying numbers | RGHT 00372 |
- Submission date
- 13/12/2006
- Registration date
- 31/03/2009
- Last edited
- 02/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Denis Harkin
Scientific
Scientific
Royal Victoria Hospital
Grosvenor Road
Belfast
Bt12 6BA
United Kingdom
Study information
| Study design | Phase II single centre prospective randomised controlled clinical 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 below to request a patient information sheet |
| Scientific title | A prospective randomised clinical trial comparing a restrictive with a standard fluid regime in patients undergoing elective infrarenal abdominal aortic aneurysm (AAA) repair |
| Study objectives | A restrictive fluid regime for elective open infra-renal abdominal aortic aneurysm (AAA) repair will improve clinical outcomes as judged primarily by a reduction in the number of patients with post-operative complications. |
| Ethics approval(s) | Northern Ireland Ethics Committee gave approval on the 8th November 2006 (ref: 06/NIR02/110) |
| Health condition(s) or problem(s) studied | Abdominal aortic aneurysm |
| Intervention | In the standard regimen patients will be given standard fluid volume intra-operatively and post-operatively until day 5, consisting of 3 litres per day. However in the restricted group, less fluid will be given intra-operatively and only 2 litres per day until day 5. Following discharge patients will be reviewed and examined at a vascular outpatient clinic at the 30-day, 3-month and 12-month post-operative stages. |
| Intervention type | Other |
| Primary outcome measure | The difference in the number of patients with post-operative complications between the restrictive and standard treated groups. |
| Secondary outcome measures | 1. Duration of hospital stay - recorded on discharge 2. Re-admission to Intensive Care Unit (ICU)/High Dependency Unit (HDU) and length of ICU/HDU stay - recorded following discharge from ICU 3. Oxygen saturation/fraction of inspired oxygen (FiO2):partial pressure of oxygen in arterial blood (PaO2) ratio - measured at baseline, and daily until day 5 4. Need for renal replacement therapy/estimated glomerular filtration rate (eGFR) - measured at baseline, and daily until day 5 5. First day of initial passage of flatus or faeces - recorded on occurrence 6. Differences in body weight - measured at baseline, and daily until day 5 7. Number of transfused platelet concentrates (PC)/fresh frozen plasma (FFP)/platelets - measured daily until day 5 8. Haematocrit - measured at baseline, and daily until day 5 9. Urinary albumin/creatinine ratio - measured at baseline, and daily until day 5 10. Sequential Organ Failure Assessment (SOFA) score - measured at baseline, and daily until day 5 |
| Overall study start date | 01/01/2007 |
| Completion date | 01/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 92 (recruitment ceased at 22 participants) |
| Key inclusion criteria | Adult patients (aged 18 years and over, either sex) admitted for elective open repair of AAA |
| Key exclusion criteria | 1. Patients with established renal failure 2. Pre-operative haematological disorder 3. Known allergy to agents specified in the standardised anaesthetic protocol 4. Lack of consent 5. Participation in other trials within 30 days |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Royal Victoria Hospital
Belfast
Bt12 6BA
United Kingdom
Bt12 6BA
United Kingdom
Sponsor information
Royal Victoria Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Grosvenor Road
Belfast
BT12 6BA
Northern Ireland
United Kingdom
"ROR" |
https://ror.org/03rq50d77 |
|---|
Funders
Funder type
Research organisation
Ulster Hospital Research Fellowship Committee (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
