the study of an antibiotic - cefuroxime - in the post-operative period in infants who have undergone cardiac surgery

Phase 1

Conditions: post operative paediatric cardiac patients
MedDRA version: 19.1Level: PTClassification code 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2016-002926-35-GB

Lead Sponsor: Alder Hey Children's Foundation NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Age from 37 weeks gestation to < 3 months
2. Patients scheduled for congenital cardiac surgery and require intensive care admission post operatively.
3. Prescription of studied medications as per standard hospital policy.
4. Intra-arterial catheter suitable for study sampling in situ.
5. Informed consent by the parent or a legally authorised representative to participate in the study and to store specimens for immediate and future analysis.

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. No informed consent
2. Investigator’s concerns
3. Non English speaking
4. No intra-arterial catheter

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish if the current dose of antibiotics, used as part of the normal pathway of care for post operative children undergoing heart operations, is optimal.;Secondary Objective: In infants undergoing corrective heart surgery, does different anatomy, physiology and iatrogenic conditions (such as peritoneal dialysis) have an impact on drug clearance from the body?;Primary end point(s): this is a PK observational study to determine the concentration of cefuroxime in this select patient population during the first 24hours post-operative period. ;Timepoint(s) of evaluation of this end point: directly post operatively, then 1 hour pre and post dose of IV cefuroxime (given at 8 hourly intervals for 24hrs)

Secondary Outcome Measures