Major elective gastrointestinal surgery Surgery
Conditions
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 65 years and over 2. Patients undergoing major elective surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes
Exclusion criteria
Exclusion criteria: 1. Inability or refusal to provide patient consent 2. Clinician refusal (including intention to monitor cardiac output from the start of surgery regardless of study group allocation) 3. American Society of Anesthesiologists (ASA) score of I 4. Patients expected to die within 30 days 5. Acute myocardial ischaemia within 30 days prior to randomisation 6. Acute pulmonary oedema within 30 days prior to randomisation 7. Contra-indication to low-dose inotropic medication 8. Pregnancy at time of enrolment 9. Previous enrolment in the OPTIMISE II trial 10. Current participation in another clinical trial of a treatment with a similar biological mechanism or primary outcome measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative infection rate within 30 days of randomisation. This is defined as one or more of the following infections of Clavien-Dindo grade II or greater: 1. Superficial surgical site infection 2. Deep surgical site infection 3. Organ space surgical site infection 4. Pneumonia 5. Urinary tract infection 6. Laboratory confirmed blood stream infection 7. Infection, source uncertain; this is defined as an infection which could be more than one of the above but it is unclear which The primary outcome will be assessed using information from a patient’s medical notes. Patients discharged from hospital before day 30 will be contacted shortly after day 30 to ascertain whether they have received any new treatment since discharge, or if they have been re-admitted to hospital or seen a doctor since discharge. For patients who have received further treatment or seen a health professional since discharge, further details will be collected directly from the hospital/doctor or from the patient’s health records. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality, assessed by a patient medical record review or data from national databases, within 180 days of randomisation 2. Acute kidney injury of Clavien-Dindo grade II or greater, assessed using a patient medical note review and telephone interview in the same way as primary outcome, within 30 days from randomisation. 3. Acute cardiac event of Clavien-Dindo grade II or greater, assessed by a review of the patient's medical notes, within 24 hours of randomisation 4. Acute cardiac event of Clavien-Dindo grade II or greater, assessed using a patient medical note review and telephone interview in the same way as primary outcome, within 30 days of randomisation. Process measures: 1. Duration of hospital stay (number of days from randomisation until hospital discharge), assessed by a review of the patient's medical records. 2. Number of critical care free days*, assessed by a review of the patient's medical records, up to 30 days from randomisation. *A critical care free day is defined as a day in which the patient is alive and is not in a level 2 or level 3 critical care bed. | — |
Countries
Australia, Canada, England, Germany, Scotland, Spain, Sweden, United Kingdom, United States of America, Wales
Contacts
Public ContactPriyanthi;Tasnin Dias;Shahid
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Outcome results
None listed