Contact information
Type
Scientific
Primary contact
Dr Patrick Doyle
ORCID ID
Contact details
Department of Anaesthesia
Imperial College Healthcare NHS Trust
Charing Cross Hospital
London
W6 8RF
United Kingdom
-
patrick.doyle@imperial.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10/H0801/2
Study information
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)
Acronym
MERIT
Study hypothesis
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
Royal Marsden Research Ethics Committee, 02/02/2010, ref: 10/H0801/2
Study design
Double-blind 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
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
Phase
Drug names
Primary outcome measures
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 trial start date
05/08/2010
Overall trial end date
05/08/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
92
Participant 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)
Recruitment start date
05/08/2010
Recruitment end date
05/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
Sponsor information
Organisation
Imperial College Healthcare NHS Trust (UK)
Sponsor details
c/o Michelle Quaye
The Joint Research Office
Hammersmith Hospital
Du Cane Road
London
W14 0HS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Imperial College Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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