Condition category
Surgery
Date applied
12/07/2012
Date assigned
14/09/2012
Last edited
12/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Williams

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RJ1 11/N160

Study information

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

Acronym

Study hypothesis

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

NRES Committee London - Westminster, ref: 11/H0802/9

Study design

Single-centre prospective double-blinded (patient & assessor) randomised non-inferiority 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

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

Phase

Drug names

Primary outcome measures

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 trial start date

24/05/2011

Overall trial end date

01/10/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

336

Participant 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

Recruitment start date

24/05/2011

Recruitment end date

01/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's & St. Thomas' NHS Foundation Trust (UK)

Sponsor details

c/o Karen Ignation
London
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Charity

Funder name

Guy's and St. Thomas' Charity (UK) ref: G100706

Alternative name(s)

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

Publication citations

Additional files

Editorial Notes