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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Intensive Care Unit
1st Floor St James' Wing
St George's Hospital
London
SW170QT
United Kingdom
| Phone | +44 (0)7718 910 440 |
|---|---|
| rupert.pearse@doctors.net.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | Incidence of post-operative complications. |
| Secondary outcome measures | Mortality and duration of hospital stay. |
| Overall study start date | 01/11/2002 |
| Completion date | 01/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Intensive Care Unit
London
SW170QT
United Kingdom
SW170QT
United Kingdom
Sponsor information
St Georges Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Blackshaw Road
London
SW17 0QT
England
United Kingdom
"ROR" |
https://ror.org/0001ke483 |
|---|
Funders
Funder type
Charity
The Intensive Care Research Fund managed by the St Georges Hospital charitable funds trustees (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
