Biochemical effects of lipopolysaccharide (LPS) adsorber treatment during cardiac surgery using cardio-pulmonary bypass
| ISRCTN | ISRCTN50922450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50922450 |
| Secondary identifying numbers | PO1192 |
- Submission date
- 02/04/2008
- Registration date
- 22/04/2008
- Last edited
- 25/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alain Vuylsteke
Scientific
Scientific
Department of Anaesthesia
Papworth Hospital NHS Foundation Trust (UK)
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Study information
| Study design | Prospective, randomised, descriptive, single-centre study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Cambridgeshire 1 Research Ethics Committee, approved on 20/06/2007 (ref: 07/Q0104/49) |
| Health condition(s) or problem(s) studied | Postoperative inflammatory complications due to raised endotoxin levels. |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 10/09/2007 |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 16 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/09/2007 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anaesthesia
Cambridge
CB23 3RE
United Kingdom
CB23 3RE
United Kingdom
Sponsor information
Papworth Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Papworth Everard
Cambridge
CB23 3RE
England
United Kingdom
| Website | http://www.papworthhospital.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01qbebb31 |
Funders
Funder type
Industry
Alteco Medical AB (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2010 | Yes | No |
