Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PO1192
Study information
Scientific title
Acronym
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
10/09/2007
Overall trial end date
30/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant 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
Recruitment start date
10/09/2007
Recruitment end date
30/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Cambridge
CB23 3RE
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Alteco Medical AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20385666
Publication citations
-
Results
De Silva RJ, Armstrong J, Bottrill F, Goldsmith K, Colah S, Vuylsteke A, A lipopolysaccharide adsorber in adult cardiopulmonary bypass: a single centre randomised controlled pilot trial., Interact Cardiovasc Thorac Surg, 2010, 11, 1, 86-92, doi: 10.1510/icvts.2010.233304.