Contact information
Type
Scientific
Primary contact
Dr John Kinsella
ORCID ID
Contact details
Department of Anaesthesia
Glasgow Royal Infirmary
University of Glasgow
8-16 Alexandra Parade
Glasgow
G4 0SF
United Kingdom
+44 (0)141 211 4625
j.kinsella@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0100043
Study information
Scientific title
Acronym
FLOES
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Fluid status in emergency laparotomy
Intervention
In the intervention group pulse pressure variation measurements were used to guide fluid boluses of 6% Hydroxyethylstarch 130/0.4
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Serum urea, creatinine and cystatin C levels were measured prior to and at the end of surgery and postoperatively on day 1, day 3 and day 5.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/05/1999
Overall trial end date
01/05/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
30
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/05/1999
Recruitment end date
01/05/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Glasgow
G4 0SF
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Government
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18424200
Publication citations
-
Results
Harten J, Crozier JE, McCreath B, Hay A, McMillan DC, McArdle CS, Kinsella J, Effect of intraoperative fluid optimisation on renal function in patients undergoing emergency abdominal surgery: a randomised controlled pilot study (ISRCTN 11799696)., Int J Surg, 2008, 6, 3, 197-204, doi: 10.1016/j.ijsu.2008.03.002.