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
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