Early goal directed therapy following major surgery reduces complications and duration of hospital stay: a randomised, controlled trial

ISRCTN	ISRCTN38797445
DOI	https://doi.org/10.1186/ISRCTN38797445
Protocol serial number	N/A
Sponsor	St Georges Hospital (UK)
Funder	The Intensive Care Research Fund managed by the St Georges Hospital charitable funds trustees (UK)

Submission date: 10/09/2005
Registration date: 28/09/2005
Last edited: 19/02/2008

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rupert Pearse
Scientific

Intensive Care Unit
1st Floor St James' Wing
St George's Hospital
London
SW170QT
United Kingdom

Phone	+44 (0)7718 910 440
Email	rupert.pearse@doctors.net.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	That post-operative goal directed therapy reduces the incidence of complications following major general surgery
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Incidence of post-operative complications.
Key secondary outcome measure(s)	Mortality and duration of hospital stay.
Completion date	01/08/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key 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
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	01/08/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Intensive Care Unit

London
SW170QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/12/2005		Yes	No