Condition category
Surgery
Date applied
02/04/2008
Date assigned
22/04/2008
Last edited
25/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alain Vuylsteke

ORCID ID

Contact details

Department of Anaesthesia
Papworth Hospital NHS Foundation Trust (UK)
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

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 measures

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

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

http://www.papworthhospital.nhs.uk

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20385666

Publication citations

  1. 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.

Additional files

Editorial Notes