Study on the benefits of fluid restriction on the recovery from surgery
| ISRCTN | ISRCTN39295230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39295230 |
| Protocol serial number | SUR011(48-04-07) |
| Sponsor | Norfolk and Norwich University Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10478) |
- Submission date
- 21/08/2008
- Registration date
- 02/10/2008
- Last edited
- 09/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Michael Lewis
Scientific
Scientific
Norfolk and Norwich University Hospital NHS Foundation Trust
Department of General Surgery
Centre Block
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
| Phone | +44 (0)1603 287583 |
|---|---|
| Michael.Lewis@nnuh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, observer-blinded trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised, observer-blinded clinical trial of post-operative fluid restriction in elective gastrointestinal surgery |
| Study objectives | The null hypothesis is that intravenous peri- and post-operative fluid restriction does not affect the rate of complications in the first 30 days following major gastrointestinal surgery. |
| Ethics approval(s) | Norfolk Research Ethics Committee gave approval on the 5th September 2007 (ref: SUR011 [48-04-07]) |
| Health condition(s) or problem(s) studied | Upper gastrointestinal and colorectal cancer resection |
| Intervention | A restricted intra- and post-operative fluid regime with the use of ephedrine instead of fluids once losses have been replaced in the event of hypotension as opposed to a standard regime of fluid replacement. All patients will have epidurals for pain relief. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ephedrine |
| Primary outcome measure(s) |
Grade II complications and above up to 30 days post-surgery. |
| Key secondary outcome measure(s) |
1. 30 day post-operative mortality |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 234 |
| Key inclusion criteria | 1. All adult patients (both males and females) undergoing elective colorectal or upper gastrointestinal surgery (gastrectomies, oesophagectomies) cancer resection at the Norfolk and Norwich University Hospital NHS Foundation Trust 2. All patients will have epidurals for pain relief |
| Key exclusion criteria | 1. American Society of Anaesthesiologists (ASA) classification 4 - 5 2. Chronic renal failure defined as a creatinine greater than 140 μmol/L 3. Congestive cardiac failure defined as New York Heart Association (NYHA) class III - IV 4. Pregnancy 5. Diabetes mellitus (excluding diet controlled) 6. Planned post-operative ventilation on intensive treatment unit (ITU) 7. Contraindication to epidural 8. Inability to give informed consent |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom
NR4 7UY
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
