Central venous oxygen levels (ScvO2) for fluid optimisation in high risk surgical patients
- Conditions
- Improving outcomes in high-risk surgical patientsSurgery
- Registration Number
- ISRCTN50142780
- Lead Sponsor
- James Cook University Hospital (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
1. Elective major open abdominal surgery (gastrointestinal, urological, gynaecological or vascular procedures with an expected duration of at least 90 minutes)
2. Requirement for invasive haemodynamic monitoring including arterial and central venous blood pressure and CO measurement
3. More than 50 years of age and at least one of the following:
3.1. Renal impairment (serum creatinine > 130 µmol/l)
3.2. Diabetes mellitus
3.3. Aged 65 years and over
3.4. Presence of a risk factor for cardiac or respiratory disease:
3.4.1. Exercise tolerance = 6 metabolic equivalents (MET?s)
3.4.2. Anaerobic threshold = 14 ml/kg/min
3.4.3. Past medical history of ischaemic heart disease
3.4.4. Heart failure
3.4.5. Moderate or severe valvular disease
3.4.6. Chronic obstructive pulmonary disease (COPD)
3.4.7. Radiographically confirmed chronic lung disease (COPD, fibrosis)
1. No consent
2. Pregnancy
3. Emergency surgery
4. Vascular surgery involving aortic cross clamping
5. Allergy to Gelofusin® and Volulyte®
6. Laparoscopic surgery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation between changes of stroke volume and hence cardiac output with changes in central venous saturation and central venous arterial partial pressure of carbon dioxide difference, respectively
- Secondary Outcome Measures
Name Time Method Sensitivity and specificity of pulse pressure and stroke volume variation and pleth variability index (PVI) to predict an increase of cardiac output by at least 10%