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| [ Print-friendly version ] |
| Biochemical effects of lipopolysaccharide (LPS) adsorber treatment during cardiac surgery using cardio-pulmonary bypass |
| ISRCTN | ISRCTN50922450 |
| ClinicalTrials.gov identifier | |
| Public title | Biochemical effects of lipopolysaccharide (LPS) adsorber treatment during cardiac surgery using cardio-pulmonary bypass |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | PO1192 |
| Study hypothesis |
Endotoxin is known to enter the blood stream during cardiac surgery using cardio-pulmonary bypass (CPB), with values peaking during reperfusion. The increase in endotoxin levels is probably caused by gut translocation due to the increased capillary permeability seen during bypass.
Endotoxins are pathogenic triggers for the production of various inflammatory mediators. Raised endotoxin levels therefore increase the risk for postoperative inflammatory complications (sepsis/ Systemic Inflammatory Response Syndrome [SIRS]) and prolonged postoperative recovery. The Alteco® LPS Adsorber (Alteco Medical AB Lund, Sweden) is an endotoxin adsorption device which has been successfully used in animal studies. It is a CE marked (CE 0088) disposable medical device designed for extracorporeal use. This descriptive study will assess the biochemical effects of Alteco® LPS Adsorber treatment during cardiac surgery using CPB. |
| Ethics approval | Cambridgeshire 1 Research Ethics Committee, approved on 20/06/2007 (ref: 07/Q0104/49) |
| Study design | Prospective, randomised, descriptive, single-centre study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Postoperative inflammatory complications due to raised endotoxin levels. |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/09/2007 |
| Anticipated end date | 30/05/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 16 |
| 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 during the whole procedure. |
| Primary outcome measure(s) |
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 outcome measure(s) |
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) |
| Sources of funding | Alteco Medical AB (Sweden) |
| Trial website | |
| Publications | |
| Contact name | Dr Alain Vuylsteke |
| Address |
Department of Anaesthesia
Papworth Hospital NHS Foundation Trust (UK) Papworth Everard |
| City/town | Cambridge |
| Zip/Postcode | CB23 3RE |
| Country | United Kingdom |
| Sponsor | Papworth Hospital NHS Foundation Trust (UK) |
| Address | Papworth Everard |
| City/town | Cambridge |
| Zip/Postcode | CB23 3RE |
| Country | United Kingdom |
| Sponsor website: | http://www.papworthhospital.nhs.uk |
| Date applied | 02/04/2008 |
| Last edited | 22/04/2008 |
| Date ISRCTN assigned | 22/04/2008 |
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