|
ISRCTN
|
ISRCTN38797445
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Early goal directed therapy following major surgery reduces complications and duration of hospital stay: a randomised, controlled trial
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
That post-operative goal directed therapy reduces the incidence of complications following major general surgery
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Major general surgery
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
01/11/2002
|
|
Anticipated end date
|
01/08/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
300
|
|
Interventions
|
Goal directed therapy protocol to achieve oxygen delivery index of 600 ml/min/m^2 compared to protocol designed to reflect standard care.
|
|
Primary outcome measure(s)
|
Incidence of post-operative complications.
|
|
Secondary outcome measure(s)
|
Mortality and duration of hospital stay.
|
|
Sources of funding
|
The Intensive Care Research Fund managed by the St Georges Hospital charitable funds trustees (UK)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/16356219
|
|
Contact name
|
Dr
Rupert
Pearse
|
|
Address
|
Intensive Care Unit
1st Floor St James' Wing
St George's Hospital
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW170QT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)7718 910 440
|
|
Email
|
rupert.pearse@doctors.net.uk
|
|
Sponsor
|
St Georges Hospital (UK)
|
|
Address
|
Blackshaw Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW17 0QT
|
|
Country
|
United Kingdom
|
|
Date applied
|
10/09/2005
|
|
Last edited
|
19/02/2008
|
|
Date ISRCTN assigned
|
28/09/2005
|
