The anti-endotoxin agent, taurolidine, potentially reduces ischaemia-reperfusion injury through its metabolite taurine

ISRCTN	ISRCTN58678663
DOI	https://doi.org/10.1186/ISRCTN58678663
Secondary identifying numbers	N/A

Submission date: 16/06/2009
Registration date: 21/07/2009
Last edited: 21/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Redmond
Scientific

Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland

Study information

Study design	Double-blinded randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Peri-operative administration of taurolidine decreases inflammatory response to cardiopulmonary bypass (CPB) and attenuates ischaemia-reperfusion (I-R) injury.
Ethics approval(s)	Ethics Committee of University College Cork (Ireland) granted approval on the 5th March 1999, as well as the Irish Medicines Board (IMB)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Taurolidine
Primary outcome measure	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 study start date	01/01/1999
Completion date	31/12/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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)
Key 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
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/2001

Locations

Countries of recruitment

Ireland

Study participating centre

Department of Surgery

Cork
-
Ireland

Sponsor information

Cork University Hospital (Ireland)
Hospital/treatment centre

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

Website	http://www.ucc.ie/en/
"ROR"	https://ror.org/04q107642

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan