The role and modulation of the adaptive immune response in human limb ischaemia reperfusion injury by ischaemic preconditioning
| ISRCTN | ISRCTN66931248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66931248 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/08/2008
- Registration date
- 28/08/2008
- Last edited
- 28/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 Michael Kerin
Scientific
Scientific
Department of Surgery
Clinical Science Institute
Newcastle Road
National University of Ireland Galway
Galway
-
Ireland
Study information
| Study design | Prospective, single-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | That local ischaemic preconditioning will alter bedside physiological parameters and systemic T cell activation, cytokine production and release in otherwise healthy patients undergoing lower limb surgery under tourniquet control. |
| Ethics approval(s) | Clinical Research Ethical Committee at University College Hospital Galway. Date of approval: 15/12/2005 (ref: 48/05) |
| Health condition(s) or problem(s) studied | Reperfusion injury |
| Intervention | Consecutive patients undergoing anterior cruciate ligament repair were randomised to surgery alone or surgery preceded by three 5 minute cycles of local ischaemic preconditioning to the operative limb within 1 hour of surgery. Surgery to include 1 hour of limb ischaemia. An operative tourniquet was placed on the upper thigh and the limb was exsanguinated using a Rhys Davies air sleeve. Tourniquet pressure was set at 100 mmHg above systolic brachial blood pressure. Ischaemia was verified by arterial doppler distal to the tourniquet. Systemic venous blood was collected on admission, at 4 and 24 hours post reperfusion (post-operatively). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Change in perioperative systemic mean arterial pressure and heart rate 2. Alterations in systemic T cell subsets as evaluated by flow cytometry, assessed on the systemic venous blood collected on admission, at 4 and 24 hours post reperfusion (post-operatively) 3. Alterations in systemic cytokine levels (Interleukin-2 [IL2] and interferon, gamma [IFNg]), assessed on the systemic venous blood collected on admission, at 4 and 24 hours post reperfusion (post-operatively) 4. Co-culture production of IL-2, IL-4, IL-10 and IFNg, assessed using the samples taken from patients 4 hours post reperfusion. Controls were taken from healthy volunteers. 5. Co-culture alteration in T cell subsets, assessed using the samples taken from patients 4 hours post reperfusion. Controls were taken from healthy volunteers. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/07/2006 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | Patients (both males and females) diagnosed with anterior cruciate ligament rupture by magnetic resonance imaging (MRI) or arthroscopy and undergoing patellar tendon graft reconstruction under tourniquet control. |
| Key exclusion criteria | 1. Age under 18 or over 45 2. Having smoked in the preceding 3 months 3. Diagnosis of systemic auto-immune condition (e.g., thyroxicosis, inflammatory bowel/ coeliac disease, rheumatoid arthritis, systemic lupus erythematosus [SLE]) 4. Diabetes 5. Concurrent medical condition 6. Pregnancy 7. Medications other than simple analgesics and non-steroidal anti-inflammatory drugs (NSAID) |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Department of Surgery
Galway
-
Ireland
-
Ireland
Sponsor information
National University of Ireland Galway (Ireland)
University/education
University/education
c/o Prof Michael Kerin
University College Hospital
Department of Surgery
Clinical Science Institute
Galway
-
Ireland
| Website | http://www.nuigalway.ie/surgery |
|---|---|
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
University/education
National University of Ireland Galway, Department of Surgery (Ireland)
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 |
