Pharmacokintetics of cefuroxime in post-operative cardiac infants
Research type
Research Study
Full title
Pharmacokinetics of post-operative Cefuroxime in infants undergoing cardiac surgery
IRAS ID
193612
Contact name
Dan Hawcutt
Contact email
Sponsor organisation
Alder Hey Children's Foundation NHS Trust
Eudract number
2016-002926-35
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Infants undergoing surgery for congenital cardiac disease are a very vulnerable patient group with a high risk of death. These patients are at risk of post-operative surgical site infections which can increase their morbidity and mortality. Peri-operative antibiotics are given to prevent these infections.
It is established that these infants have differing methods and abilities to clear drugs from their bodies, and as a result of this, the antibiotics given post-operatively may not be the correct dosage, rendering them higher risk of surgical site infection. This has not been studied previously.
These patients are given an antibiotic named cefuroxime during and after the operation for at least 24 hours. We plan to measure cefuroxime levels in these patients by taking regular samples of blood over this 24 hour period. Once the samples have been taken we will analyse them to establish if the dose of cefuroxime given, is too high or too low. If the level is too low, then these patients may be at higher risk of surgical site infection, and if the level is too high this could potentially cause toxicity.
We plan to identify appropriate patients and obtain consent before the operation. We will then follow them through after the operation and take approximately four samples of blood from catheters already placed in the patient's artery by the anaesthetist. We then plan to analyse these samples to establish whether the level of cefuroxime is appropriate.
We plan to enrol around 20 patients from Alder Hey Children's Foundation Trust. The samples will be taken when the infants are in the paediatric intensive care unit in the post-operative period. We aim for the study to be completed in under six months.REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0562
Date of REC Opinion
16 Aug 2016
REC opinion
Favourable Opinion