Biochemical effects of lipopolysaccharide (LPS) adsorber treatment during cardiac surgery using cardio-pulmonary bypass

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50922450

Enrollment

Registered

2008-04-22

Start date

2007-09-10

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Postoperative inflammatory complications due to raised endotoxin levels. Surgery Complications of cardiac and vascular prosthetic devices, implants and grafts

Interventions

All patients will undergo cardiac surgery using CPB according to clinical routines. In patients randomised to the adsorber treatment, Alteco® LPS Adsorber will be incorporated in the CPB circuit durin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years, both male and female 2. Patients scheduled for elective complex combined cardiac surgery using CPB 3. Patients scheduled to have cardiac surgery with estimated CPB time in excess of 60 minutes 4. Informed consent

Exclusion criteria

Exclusion criteria: 1. Planned hypothermia (core temperature <28°C) during surgery 2. Use of steroids in last six months 3. Undergoing immunosuppressive therapy 4. Anaemia (preoperative haemoglobin <10 g/dL) 5. Haematological malignancy 6. Disease of the immune system 7. Female patients of childbearing age 8. Participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
1. Endotoxin (lipopolysaccharide [LPS]) 2. Interleukin-1 (IL1), IL4, IL6, IL8 and IL10 3. Tumor necrosis factor (TNF)-alpha The above are assessed at the following timepoints: t0: After anaesthesia before CPB t60: 60 minutes after the start of CPB t180: 180 minutes after the start of CPB t360: 360 minutes after the start of CPB tPOST: 24 hours after the start of CPB (+/- 1 hour)	—

Secondary

Measure	Time frame
1. White blood cells (WBC) 2. Red blood cells (RBC) 3. Haemoglobin (Hb) 4. Hematocrit (HCT) 5. Platelet count, 6. C-reactive protein (CRP) 7. Complement activation 8. Creatinine 9. Blood glucose levels 10. Lactate 11. Thromboelastography (TEG®) 12. Record of mixed venous oxygen saturation (SvO2) during CPB 13. Length of intensive care unit (ICU) stay 14. Adverse events (AEs), recorded untill time point tPOST (with a follow-up made to R&D if continue longer than tPOST) Timepoints of assessment for outcomes 1-12 above: t0: After anaesthesia before CPB t60: 60 minutes after the start of CPB (except CRP, creatinine and TEG®) t180: 180 minutes after the start of CPB (except CRP, creatinine and TEG®) t360: 360 minutes after the start of CPB tPOST: 24 hours after the start of CPB (+/- 1 hour)	—

Measure

Time frame

1. White blood cells (WBC) 2. Red blood cells (RBC) 3. Haemoglobin (Hb) 4. Hematocrit (HCT) 5. Platelet count, 6. C-reactive protein (CRP) 7. Complement activation 8. Creatinine 9. Blood glucose levels 10. Lactate 11. Thromboelastography (TEG®) 12. Record of mixed venous oxygen saturation (SvO2) during CPB 13. Length of intensive care unit (ICU) stay 14. Adverse events (AEs), recorded untill time point tPOST (with a follow-up made to R&D if continue longer than tPOST) Timepoints of assessment for outcomes 1-12 above: t0: After anaesthesia before CPB t60: 60 minutes after the start of CPB (except CRP, creatinine and TEG®) t180: 180 minutes after the start of CPB (except CRP, creatinine and TEG®) t360: 360 minutes after the start of CPB tPOST: 24 hours after the start of CPB (+/- 1 hour)

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Countries

United Kingdom

Outcome results

None listed

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