Contact information
Type
Scientific
Primary contact
Mr Michael Lewis
ORCID ID
Contact details
Norfolk and Norwich University Hospital NHS Foundation Trust
Department of General Surgery
Centre Block
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 287583
Michael.Lewis@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SUR011(48-04-07)
Study information
Scientific title
A randomised, observer-blinded clinical trial of post-operative fluid restriction in elective gastrointestinal surgery
Acronym
Study hypothesis
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
Norfolk Research Ethics Committee gave approval on the 5th September 2007 (ref: SUR011 [48-04-07])
Study design
Randomised, observer-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Ephedrine
Primary outcome measures
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 trial start date
01/10/2007
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
234
Participant 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
Recruitment start date
01/10/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
Sponsor details
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0706-10478)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24227358
Publication citations
-
Results
Kalyan JP, Rosbergen M, Pal N, Sargen K, Fletcher SJ, Nunn DL, Clark A, Williams MR, Lewis MP, Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery., Br J Surg, 2013, 100, 13, 1739-1746, doi: 10.1002/bjs.9301.