The anti-endotoxin agent, taurolidine, potentially reduces ischaemia-reperfusion injury through its metabolite taurine
| ISRCTN | ISRCTN58678663 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58678663 |
| Protocol serial number | N/A |
| Sponsor | Cork University Hospital (Ireland) |
| Funder | Cork University Hospital (Ireland) - Department of Academic Surgery, University College Cork |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Surgery
Cork University Hospital
Wilton
Cork
-
Ireland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blinded randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Taurolidine |
| Primary outcome measure(s) |
Cytokines interleukin-6 (IL-6) and interleukin-10 (IL-10), measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping |
| Key secondary outcome measure(s) |
1. CD11b and CD14 receptor expression, measured immediately pre-operatively, at aortic unclamping, two, six and 24-hours post-unclamping |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
-
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
