Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/06/2009
Date assigned
21/07/2009
Last edited
21/07/2009
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

Prof Paul Redmond

ORCID ID

Contact details

Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

An investigation into the efficacy of the anti-endotoxin agent, taurolidine in the attenuation of the post-reperfusion sequelae in patients subjected to cardio-pulmonary bypass: a double-blinded randomised clinical trial

Acronym

Study hypothesis

Peri-operative administration of taurolidine decreases inflammatory response to cardiopulmonary bypass (CPB) and attenuates ischaemia-reperfusion (I-R) injury.

Ethics approval

Ethics Committee of University College Cork (Ireland) granted approval on the 5th March 1999, as well as the Irish Medicines Board (IMB)

Study design

Double-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ischaemia-reperfusion injury

Intervention

From induction of anaesthesia, patients were administered 250 ml of 2% taurolidine or normal saline twice daily intravenously for 3 doses in total.

Intervention type

Drug

Phase

Not Applicable

Drug names

Taurolidine

Primary outcome measures

Cytokines interleukin-6 (IL-6) and interleukin-10 (IL-10), measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping

Secondary outcome measures

1. CD11b and CD14 receptor expression, measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping
2. Respiratory burst and phagocytosis of circulating neutrophils, measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping
3. Plasma lipopolysaccharide (LPS), measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping
4. Arrhythmias, analysed intra-operatively and daily up until hospital discharge
5. Complications, analysed intra-operatively and daily up until hospital discharge

Overall trial start date

01/01/1999

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (aged greater than or equal to 18 years, either sex) undergoing elective coronary artery bypass grafting
2. Left ventricular ejection fraction greater than 30% (affects likelihood of developing infection post-operatively for various reasons including increased inotropic support requirements, longer intensive care unit [ICU] stay, delayed mobilisation, and delayed removal of urinary catheters and intravenous lines)
3. Normal pulmonary function tests (affects likelihood of developing respiratory complications post-operatively)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients with diabetes mellitus (affects likelihood of developing infection post-operatively)
2. Patients taking angiotensin-converting enzyme inhibitors (affects potential to reduce reperfusion injury by acting on leukocytes)
3. Patients taking steroids (more prone to developing infection)
4. Patients with chronic arrhythmias

Recruitment start date

01/01/1999

Recruitment end date

31/12/2001

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of Surgery
Cork
-
Ireland

Sponsor information

Organisation

Cork University Hospital (Ireland)

Sponsor details

c/o Professor H.P. Redmond
Department of Academic Surgery
University College Cork
Cork
-
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.ucc.ie/en/

Funders

Funder type

Hospital/treatment centre

Funder name

Cork University Hospital (Ireland) - Department of Academic Surgery, University College Cork

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

Publication citations

Additional files

Editorial Notes