Condition category
Surgery
Date applied
04/10/2006
Date assigned
29/01/2007
Last edited
12/08/2010
Prospective/Retrospective
Prospectively 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 Rupert Pearse

ORCID ID

Contact details

5th floor
38 Little Britain
St Bartholomew’s Hospital
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 7526
rupert.pearse@bartsandthelondon.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R&D ref: 004670

Study information

Scientific title

Acronym

Study hypothesis

To assess whether post-operative Goal Directed Therapy results in improved clinical outcomes through enhanced tissue perfusion and oxygenation.

Please note that as of 23/10/2007 this application was amended. The amendment will allow us to compare the effects on tissue perfusion and oxygenation of post-operative Goal Directed Therapy with intravenous fluid alone and that of Goal Directed Therapy with fluid plus dopexamine. All changes relating to these amendments will be noted under the date '23/10/2007'. These amendments have included the addition of two funders, a change to the target number of participants (as of 17/04/2007 this was updated to 80, and was originally entered as 120), a change to the anticipated start date (this was originally 01/12/2006) and an addition to the interventions.

Ethics approval

Approved by the London Multi-Centre Research Ethics Committee on the 17th November 2006 (ref: 06/MRE02/70).

Study design

Randomised single centre, single blind, study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Major abdominal surgery

Intervention

In addition to maintenance fluid, control group patients will receive additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in central venous pressure.

In addition to maintenance fluid, intervention group patients will receive additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in stroke volume. Patients in the intervention group will also receive dopexamine at a fixed rate of 0.5 mcg/kg/min.

As of 17/04/2007:
Due to funding problems we will only be able to recruit enough patients for our secondary outcome measure therefore only 80 participants are expected to be recruited.

As of 23/10/2007:
A second intervention group will receive, in addition to maintenance fluid, additional 250 ml fluid challenges with colloid solution as required, to achieve a sustained rise in stroke volume but this will not be supplemented with dopexamine.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Reduction in post-operative complication rates associated with the use of Goal Directed Therapy.

Added as of 23/10/2007:
Increase in tissue oxygenation associated with the use of Goal Directed Therapy.

Secondary outcome measures

1. Reduction in microvascular perfusion associated with the use of Goal Directed Therapy
2. Reduction in tissue oxygenation associated with the use of Goal Directed Therapy
3. Reduction in post-operative duration of hospital stay associated with the use of Goal Directed Therapy
4. Reduction in post-operative mortality associated with the use of Goal Directed Therapy

Overall trial start date

01/11/2007

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients admitted to intensive care or high dependency unit following elective major abdominal surgery

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

135 (45 per group) (added 23/10/2007)

Participant exclusion criteria

1. Refusal of consent
2. Concurrent lithium therapy
3. Acute myocardial ischaemia
4. Acute arrhythmias
5. Pregnancy
6. Patients receiving palliative treatment only
7. Weight less than 40 kg

Recruitment start date

01/11/2007

Recruitment end date

01/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

5th floor
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Queen Mary's University of London (UK)

Sponsor details

Joint R&D Office
3rd Floor Rutland House
42−46 New Road
Whitechapel
London
E1 2AX
United Kingdom

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Industry

Funder name

In decreasing order of size:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Circassia Ltd (UK) - research grant (added 23/10/2007)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Barts and the London Charity (UK) - research grant (added 23/10/2007)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Unrestricted educational grant: Zeneus Pharma Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Unrestricted educational grant: LiDCO Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Society of Intensive Care Medicine Intelligent Monitoring Award (Europe)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20698956

Publication citations

  1. Results

    Jhanji S, Vivian-Smith A, Lucena-Amaro S, Watson D, Hinds CJ, Pearse RM, Haemodynamic optimisation improves tissue microvascular flow and oxygenation after major surgery: a randomised controlled trial., Crit Care, 2010, 14, 4, R151, doi: 10.1186/cc9220.

Additional files

Editorial Notes