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

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

Email patrick.doyle@imperial.nhs.uk

Study information

Study designDouble-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymMERIT
Study objectivesDoes 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) studiedSquamous cell carcinoma of the upper aerodigestive tract
InterventionThe 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 typeProcedure/Surgery
Primary outcome measureIncidence 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 measures1. 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 date05/08/2010
Completion date05/08/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants92
Key inclusion criteria1. 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 criteria1. 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 enrolment05/08/2010
Date of final enrolment05/08/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Charing Cross Hospital
London
W6 8RF
United Kingdom

Sponsor information

Imperial College Healthcare NHS Trust (UK)
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 logo "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)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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