Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rupert Pearse

ORCID ID

Contact details

Intensive Care Unit
1st Floor St James' Wing
St George's Hospital
London
SW170QT
United Kingdom
+44 (0)7718 910 440
rupert.pearse@doctors.net.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

That post-operative goal directed therapy reduces the incidence of complications following major general surgery

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

Treatment

Patient information sheet

Condition

Major general surgery

Intervention

Goal directed therapy protocol to achieve oxygen delivery index of 600 ml/min/m^2 compared to protocol designed to reflect standard care.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of post-operative complications.

Secondary outcome measures

Mortality and duration of hospital stay.

Overall trial start date

01/11/2002

Overall trial end date

01/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 18 years or older presenting for major surgery expected to last more than one and a half hours were eligible for inclusion if one or more of the following criteria were satisfied before surgery:
1. Severe cardiac or respiratory illness resulting in severe functional limitation
2. Extensive surgery planned for carcinoma involving bowel anastamosis
3. Acute massive blood loss (greater than 2.5 l)
4. Aged over 70 years with moderate functional limitation of one or more organ systems
5. Septicaemia (positive blood cultures or septic focus)
6. Respiratory failure (partial pressure of oxygen in arterial blood [PaO2] less than 8 kPa on Fraction of inspired Oxygen [FiO2] greater than 0.4, i.e., PaO2 : FiO2 ratio less than 20 kPa or ventilation greater than 48 hours)
7. Acute abdominal catastrophe (e.g., pancreatitis, perforated viscous, gastro-intestinal bleed)
8. Acute renal failure (urea greater than or equal to 20 mmol/l, creatinine greater than 60 µmol/l)
9. Surgery for abdominal aortic aneurysm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Refusal of consent
2. Pregnancy
3. Acute myocardial ischaemia prior to enrolment
4. Patients receiving palliative treatment only
5. Disseminated malignancy
6. Patients unlikely to survive more than 6 hours
7. Patients requiring intervention outside intensive care unit (ICU) within the first 6 hours following surgery
8. Patients on lithium therapy
9. Weight less than 40 kg

Recruitment start date

01/11/2002

Recruitment end date

01/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Intensive Care Unit
London
SW170QT
United Kingdom

Sponsor information

Organisation

St Georges Hospital (UK)

Sponsor details

Blackshaw Road
London
SW17 0QT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

The Intensive Care Research Fund managed by the St Georges Hospital charitable funds trustees (UK)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/16356219

Publication citations

  1. Results

    Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED, Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]., Crit Care, 2005, 9, 6, R687-93, doi: 10.1186/cc3887.

Editorial Notes