Remote ischaemic preconditioning to reduce myocardial complications following head and neck cancer surgery
| ISRCTN | ISRCTN82938832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82938832 |
| Secondary identifying numbers | 10/H0801/2 |
- Submission date
- 07/07/2010
- Registration date
- 29/07/2010
- Last edited
- 25/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Dr Patrick Doyle
Scientific
Scientific
Department of Anaesthesia
Imperial College Healthcare NHS Trust
Charing Cross Hospital
London
W6 8RF
United Kingdom
| patrick.doyle@imperial.nhs.uk |
Study information
| Study design | Double-blind 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 | A prospective double-blind randomised controlled trial of the impact of remote-organ ischaemic preconditioning on perioperative myocardial morbidity and postoperative complications in head and neck surgery: Myocardial Event Reduction with Ischaemic-preconditioning Therapy (MERIT) |
| Study acronym | MERIT |
| Study objectives | Does remote ischaemic preconditioning reduce the incidence of myocardial damage associated with major head and neck surgery? As a secondary hypothesis, does remote ischaemic preconditioning reduce the degree of post-operative inflammation, the number and severity of post-operative complications, length of critical care stay, and the overall duration of hospitalisation? |
| Ethics approval(s) | Royal Marsden Research Ethics Committee, 02/02/2010, ref: 10/H0801/2 |
| Health condition(s) or problem(s) studied | Squamous cell carcinoma of the upper aerodigestive tract |
| Intervention | The intervention group will receive remote ischaemic preconditioning which will be achieved immediately after induction of anaesthesia using an orthopaedic lower limb tourniquet inflated to 50 mmHg above the systolic pressure for two cycles of five minutes, interleaved with a single seven-minute period of reperfusion. The control group will not have remote ischaemic preconditioning; they will have a lower limb torniquet placed around their leg but this will not be inflated. The duration of treatment is 20 minutes and the follow-up is six months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Incidence of myocardial injury following head and neck surgery, as measured by the level of cardiac troponin enzyme at days 1, 3 and 7 after the operation. |
| Secondary outcome measures | 1. The rate of rise of C-reactive protein levels in the post-operative period (the inflammatory gradient) 2. Incidence and severity of post-operative complications as graded on a validated complications grading system 3. Length of stay in the Intensive Care, High-dependency and ward 4. Patient weight and swallowing status during follow-up 5. One-year MACE (Major Acute Cardiovascular Event) rate |
| Overall study start date | 05/08/2010 |
| Completion date | 05/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 92 |
| Key inclusion criteria | 1. Patients aged under 90 years, either sex 2. Squamous cell carcinoma of the upper aerodigestive tract (head and neck cancer) 3. Undergoing excision of the primary site tumour and removal of cervical lymph nodes as part of the management of their condition |
| Key exclusion criteria | 1. Patients over 90 years of age 2. Patients unable to give informed consent 3. Patients unfit to undergo general anaesthesia 4. Patients undergoing only neck dissection surgery 5. Patients with non-squamous cell carcinoma pathology 6. Patients undergoing excision of tumours of the skull base 7. Diabetic patients taking sulphonylurea medications 8. Patients taking nicorandil 9. Patients undergoing trans-oral laser resection of tumours 10. Patients with a previous history of deep-vein thrombosis or pulmonary embolism 11. Patients with known peripheral vascular disease who have an Ankle-Brachial Pressure Index less than 0.7) |
| Date of first enrolment | 05/08/2010 |
| Date of final enrolment | 05/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Michelle Quaye
The Joint Research Office
Hammersmith Hospital
Du Cane Road
London
W14 0HS
England
United Kingdom
| Website | http://www.imperial.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Hospital/treatment centre
Imperial College Healthcare NHS Trust (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Imperial NHS, imperialnhs, Imperial College Healthcare NHS Trust | London
- Location
- United Kingdom
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 |
Editorial Notes
25/04/2018: No publications found, verifying study status with principal investigator
03/03/2016: No publications found, verifying study status with principal investigator
