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Fat Filtration and Organ Injury following Cardiac Surgery

Quantification of lipid and leukocyte filtration and the effects on cerebral and renal injury markers and pulmonary function during cardiopulmonary bypass.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56462370
Enrollment
50
Registered
2010-09-20
Start date
2010-09-06
Completion date
Unknown
Last updated
2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary bypass Surgery

Interventions

Use of the RemoweLL Oxygenator containing a lipid and leucocyte depleting filter against current standard oxygenator during cardiopulmonary bypass for patients undergoing coronary artery bypass grafti

Sponsors

Eurosets s.r.l. (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 30) 7. Pre-operative heparin regime 8. Abnormal preoperative white cell count (10x109 cells/L) 9. Renal failure (serum creatinine >150µmol/L)

Design outcomes

Primary

MeasureTime frame
1. Concentration of lipid microemboli measured using light microscopy and Oil Red O staining before and after cardiopulmonary bypass compared to control 2. Percentage of activated leucocytes using flow cytometry marker CD11b before and after cardiopulmonary bypass compared to control

Secondary

MeasureTime frame
Levels of biochemical markers of organ injury, specifically 1. Brain (neuron-specific enolase [NSE]) 2. Kidneys (Cystatin C and standard laboratory tests) and 3. Pulmonary function as measured by calculation of the respiratory index Comparison between before and after results with trial and standard oxygenator.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026