Condition category
Signs and Symptoms
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
16/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes