Condition category
Cancer
Date applied
07/07/2010
Date assigned
29/07/2010
Last edited
03/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.imperial.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

03/03/2016: No publications found, verifying study status with principal investigator