Study on the benefits of fluid restriction on the recovery from surgery
| ISRCTN | ISRCTN39295230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39295230 |
| Secondary identifying numbers | SUR011(48-04-07) |
- 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
| Study design | Randomised, observer-blinded 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 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ephedrine |
| Primary outcome measure | Grade II complications and above up to 30 days post-surgery. |
| Secondary outcome measures | 1. 30 day post-operative mortality 2. Length of hospital stay 3. Post-operative hypotensive episodes. Duration of follow-up: 5 days post-operatively. |
| Overall study start date | 01/10/2007 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
England
United Kingdom
| Website | http://www.nnuh.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01wspv808 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10478)
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 | 01/12/2013 | Yes | No |
