Comparison of outcomes of goal-directed fluid optimisation guided by LiDCOrapid and conventional oesophageal Doppler

ISRCTN	ISRCTN50251697
DOI	https://doi.org/10.1186/ISRCTN50251697
Secondary identifying numbers	RJ1 11/N160

Submission date: 12/07/2012
Registration date: 14/09/2012
Last edited: 27/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Cardiac output is the volume of blood pumped by the heart per minute. Monitoring the cardiac output to guide fluid administration has been shown to benefit patients undergoing major colorectal surgery, improving their outcomes and reducing the length of hospital stay. The aim of this study is to detect any differences in patient outcome with the use of the LiDCOrapid monitor compared with conventional oesophageal Doppler monitoring.

Who can participate?
Patients undergoing elective colorectal surgery.

What does the study involve?
Both monitors are set up and the participant is randomly allocated to have their fluid administration guided by either LiDCOrapid or oesophageal Doppler. The anaesthetist is not able to see the measurements from the other monitor, but paired measurements are taken throughout. Patient outcomes are collected during their hospital stay and follow-up.

What are the possible benefits and risks of participating?
There is established evidence behind the use of both LiDCO and oesophageal Doppler monitoring and both are already in widespread use. An interim analysis will take place once half of the participants have been recruited to avoid harm if significant differences in outcome are detected.

Where is the study run from?
St Thomas' Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2011 to October 2013

Who is funding the study?
Guy's and St Thomas' Charity (UK)

Who are the main contacts?
Mr Jonathan van Dellen (Research Fellow) - jvandellen@doctors.org.uk
Mr Andrew Williams (Consultant Colorectal Surgeon)
Dr Stuart McCorkell (Consultant Anaesthesist)

Contact information

Mr Andrew Williams
Scientific

Department of Colorectal Surgery
St. Thomas' Hospital
Guy's & St. Thomas' NHS Foundation Trust
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Study information

Study design	Single-centre prospective double-blinded (patient & assessor) randomised non-inferiority 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	Comparison of goal-directed fluid optimisation guided by LiDCOrapid and conventional oesophageal Doppler effect on intra-operative oxygen delivery index and post-operative outcomes: a randomised control non-inferiority study
Study objectives	Intra-operative goal-directed fluid optimisation guided by LiDCOrapid achieves non-inferior oxygen delivery index optimisation and equivalent patient outcomes compared to oesophageal Doppler monitoring.
Ethics approval(s)	NRES Committee London - Westminster, ref: 11/H0802/9
Health condition(s) or problem(s) studied	Improving perioperative care for elective colorectal surgery
Intervention	Anaesthetist randomised to use either: 1. LiDCOrapid in intervention group OR 2. Conventional oesophageal Doppler cardiac output monitoring in control arm to guide goal-directed fluid therapy Both monitors will be attached intraoperatively to allow paired readings. The anaesthetist will be blinded to the measurements of other monitor not being used.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Post-operative length of stay (in days)
Secondary outcome measures	1. Intra-operative oxygen delivery index values 2. Intra-operative intravenous fluid volumes 3. Intra-operative differences in % change stroke volume 4. Morbidity 5. Functional recovery (mobility and return of gastrointestinal function) 6. In-hospital and 30-day mortality
Overall study start date	24/05/2011
Completion date	01/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	336
Key inclusion criteria	1. Elective or semi-elective patients due to undergo colorectal surgery as part of Enhanced Recovery Protocol 2. Successful simultaneous LiDCOrapid and oesophageal Doppler monitoring throughout surgery
Key exclusion criteria	1. Emergency surgery 2. Lack of capacity to consent 3. Pregnancy 4. All excluded patients from patient groups to be reported in results 5. Contraindications to oesophageal Doppler probe 5.1. nasal injuries or polyps 5.2. severe oesophageal/laryngeal/pharyngeal disease 5.3. recent oesophageal/laryngeal/pharyngeal surgery 5.4. thoracic aortic aneurysm 5.5. severe bleeding diathesis 5.6. long-term systemic steroid therapy 5.7. portal hypertension 6. Contraindications to arterial line or LiDCOrapid 6.1. weight <40kg 6.2. aortic valve regurgitation
Date of first enrolment	24/05/2011
Date of final enrolment	01/10/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St Thomas' Hospital

London
SE1 7EH
United Kingdom

Sponsor information

Guy's & St. Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Karen Ignation
London
SE1 7EH
England
United Kingdom

Website	http://www.guysandstthomas.nhs.uk/
"ROR"	https://ror.org/00j161312

Funders

Funder type

Charity

Guy's and St. Thomas' Charity (UK) ref: G100706
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location: United Kingdom

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

Editorial Notes

27/02/2018: No publications found in PubMed.