Fat Filtration and Organ Injury following Cardiac Surgery
- Conditions
- Cardiopulmonary bypassSurgery
- Registration Number
- ISRCTN56462370
- Lead Sponsor
- Eurosets s.r.l. (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Participant is willing and able to give informed consent for participation in the study - any documented history of cognitive impairment will exclude the patient as this may have an effect on biochemical markers of cerebral injury
2. Male or female, aged 18 years or above
3. Patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery
4. Angiographically proven coronary artery stenosis
1. Age less than 18 or more than 90 years old
2. Emergency CABG surgery
3. Previous CABG surgery
4. Gross haemodynamic instability:
4.1. Hypertension (systolic blood pressure >160mmHg)
4.2. Hypotension (systolic blood pressure <90mmHg)
4.3. Bradycardia (heart rate <60 beats/min)
5. Diabetes
6. Obesity (BMI >30)
7. Pre-operative heparin regime
8. Abnormal preoperative white cell count (<4 or >10x109 cells/L)
9. Renal failure (serum creatinine >150µmol/L)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Concentration of lipid microemboli measured using light microscopy and Oil Red O staining before and after cardiopulmonary bypass compared to control<br>2. Percentage of activated leucocytes using flow cytometry marker CD11b before and after cardiopulmonary bypass compared to control
- Secondary Outcome Measures
Name Time Method evels of biochemical markers of organ injury, specifically <br>1. Brain (neuron-specific enolase [NSE])<br>2. Kidneys (Cystatin C and standard laboratory tests) and <br>3. Pulmonary function as measured by calculation of the respiratory index<br>Comparison between before and after results with trial and standard oxygenator.