EAM safety study V1.0

• Research type

  Research Study

• Full title

  Clinical safety study of a novel Esmolol/Adenosine/Magnesium (EAM) cardioplegia concentrate

• IRAS ID

  259192

• Contact name

  Christopher Blauth

• Contact email

  christopher.blauth@gstt.nhs.uk

• Sponsor organisation

  Guy's and St Thomas' NHS Foundation Trust

• Eudract number

  2019-000712-29

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Cardiac surgeons require an arrested heart for the best technical operation; however, arrest (and no blood supply of oxygen or nutrients) is damaging to hearts. A special ‘cardioplegia’ solution is used to protect the heart during arrest, but conventional cardioplegia, using high potassium levels, has less than optimal protection. We devised a novel cardioplegia, using a combination of 3 non-toxic and rapidly reversible drugs (esmolol, adenosine and magnesium), and have shown in many animal heart studies that it improves protection to the heart. We now wish to examine whether it is safe for use in human hearts during cardiac surgery.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  19/LO/1326

• Date of REC Opinion

  31 Oct 2019

• REC opinion

  Further Information Favourable Opinion