THERMIC-3
Research type
Research Study
Full title
Intermittent Antegrade Warm Blood versus Cold Blood Cardioplegia in Children Undergoing Open Heart Surgery: A Randomised Controlled Trial (THERMIC-3)
IRAS ID
211278
Contact name
Serban Stoica
Contact email
Sponsor organisation
University Hospitals Bristol NHS Trust
ISRCTN Number
ISRCTN13467772
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Congenital heart disease is not uncommon and morbidity following cardiac surgery in children remains significant. Surgical repair of congenital heart defects usually requires the heart to be stopped using a cold solution containing potassium (cardioplegia) which protects the heart and keeps it still when operating. We have previously shown that cold cardioplegia solutions may have deleterious effects on the recovery of the heart after surgery in adults. However, very little is known about the effects of using warm cardioplegia solutions in children. Therefore, we will assign children undergoing open heart surgery by chance to one of two groups, using either warm or cold cardioplegia solutions to stop and protect the heart. Clinical and biochemical measures of recovery and complications following surgery will be compared between the two groups.
A sub-study will also look at methods for measuring core body temperature monitoring in children undergoing cardiac surgery with cardiopulmonary bypass. Temperature monitoring is an essential and a universally measured sign in the management of critically ill children. Rectal temperature monitoring is currently the most commonly used method for estimation of the core body temperature in ill children. Multiple studies in adults and children have questioned the accuracy of rectal temperature monitoring when compared to pulmonary artery or urinary catheter monitoring. However, these studies are limited by small numbers. The sub study is a proof of concept study, which will compare measurements of core body temperature obtained using a temperature sensing urinary catheter and a rectal temperature probe and other temperature measuring devices such as axillary, oral, aural and oesophageal probes.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0205
Date of REC Opinion
7 Mar 2018
REC opinion
Favourable Opinion