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

Pharmacokinetics of post-operative Cefuroxime in infants undergoing cardiac surgery - Pharmacokintetics of cefuroxime in post-operative cardiac infants

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002926-35-GB

Enrollment

Unknown

Registered

2017-01-13

Start date

2017-01-16

Completion date

Unknown

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post operative paediatric cardiac patients MedDRA version: 19.1 Level: PT Classification code 10053840 Term: Bacterial sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Cefuroxime Product Name: cefuroxime Pharmaceutical Form: Powder for injection INN or Proposed INN: cefuroxime CAS Number: 55268-75-2 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age from 37 weeks gestation to =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026