Remote ischaemic preconditioning to reduce myocardial complications following head and neck cancer surgery

ISRCTN	ISRCTN82938832
DOI	https://doi.org/10.1186/ISRCTN82938832
Protocol serial number	10/H0801/2
Sponsor	Imperial College Healthcare NHS Trust (UK)
Funder	Imperial College Healthcare NHS Trust (UK)

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

Department of Anaesthesia
Imperial College Healthcare NHS Trust
Charing Cross Hospital
London
W6 8RF
United Kingdom

Email	patrick.doyle@imperial.nhs.uk

Study information

Primary study design	Interventional
Study design	Double-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	05/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Charing Cross Hospital

London
W6 8RF
United Kingdom

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

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