Biochemical effects of lipopolysaccharide (LPS) adsorber treatment during cardiac surgery using cardio-pulmonary bypass
| ISRCTN | ISRCTN50922450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50922450 |
| Protocol serial number | PO1192 |
| Sponsor | Papworth Hospital NHS Foundation Trust (UK) |
| Funder | Alteco Medical AB (Sweden) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Anaesthesia
Papworth Hospital NHS Foundation Trust (UK)
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, descriptive, single-centre study. |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Endotoxin (lipopolysaccharide [LPS]) |
| Key secondary outcome measure(s) |
1. White blood cells (WBC) |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
CB23 3RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
