The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001183279
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
17/07/2018
Date last updated
17/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determination of perioperative levels of cefazolin in paediatric cardiac surgical patients
Scientific title
Determination of perioperative levels of cefazolin in paediatric cardiac surgical patients
Secondary ID [1] 295228 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital heart disease 308384 0
Condition category
Condition code
Cardiovascular 307377 307377 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Paediatric cardiac surgery requiring cardiopulmonary bypass with or without deep hypothermia (<25 degrees Celcius). Decision to use deep hypothermic arrest is at the surgeons discretion and is based on the surgical procedure to be undertaken. Commonly deep hypothermic arrest is used for Norwood procedures and procedures involving the aortic arch. Observation (blood tests) will be at eight timepoints during the operative period
Intervention code [1] 301564 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306348 0
Achievement of minimum inhibitory concentration (1mcg/ml for gram positive organisms and 8mcg/ml for gram negative organisms) of cefazolin. Data will be extracted from the hospital medical records.
Timepoint [1] 306348 0
Perioperatively:
1. Five minutes post initial dose;
2. At start of bypass;
3. Five minutes post start of bypass;
4. Thirty minutes post start of bypass;
5. Before rewarming;
6. Before second dose;
7. Five minutes after second dose;
8. On wound closure.
Secondary outcome [1] 348243 0
Effect of age (neonate/infant/child or school age) on achievement of minimum inhibitory concentration of cefazolin. Data will be extracted from the hospital medical records.
Timepoint [1] 348243 0
Perioperatively:
1. Five minutes post initial dose;
2. At start of bypass;
3. Five minutes post start of bypass;
4. Thirty minutes post start of bypass;
5. Before rewarming;
6. Before second dose;
7. Five minutes after second dose;
8. On wound closure.
Secondary outcome [2] 348304 0
Effect of long cardiopulmonary bypass (>120 minutes) on achievement of minimum inhibitory concentration of cefazolin. Data will be extracted from the hospital medical records.
Timepoint [2] 348304 0
Perioperatively:
1. Five minutes post initial dose;
2. At start of bypass;
3. Five minutes post start of bypass;
4. Thirty minutes post start of bypass;
5. Before rewarming;
6. Before second dose;
7. Five minutes after second dose;
8. On wound closure.
Secondary outcome [3] 348305 0
Effect of deep hypothermia (</= 25 degrees celcius) on achievement of minimum inhibitory concentration of cefazolin. Data will be extracted from the hospital medical records.
Timepoint [3] 348305 0
Perioperatively:
1. Five minutes post initial dose;
2. At start of bypass;
3. Five minutes post start of bypass;
4. Thirty minutes post start of bypass;
5. Before rewarming;
6. Before second dose;
7. Five minutes after second dose;
8. On wound closure.
Secondary outcome [4] 348306 0
Effect of extracorporeal membrane oxygenation (ECMO) on achievement of minimum inhibitory concentration of cefazolin. Data will be extracted from the hospital medical records.
Timepoint [4] 348306 0
Perioperatively:
1. Five minutes post initial dose;
2. At start of bypass;
3. Five minutes post start of bypass;
4. Thirty minutes post start of bypass;
5. Before rewarming;
6. Before second dose;
7. Five minutes after second dose;
8. On wound closure.

Eligibility
Key inclusion criteria
Cardiac surgery involving cardiopulmonary bypass
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing apparent infectious disease
Renal failure (serum urea concentration > 6 mmol/l, serum creatinine > 100 µmol/l, anuria)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data derived from the study patients will be analysed and with appropriate co-variables will be entered into fit for purpose modelling software 32 whereby additional dosing regimens can be evaluated using the subject data to simulate alternative regimens. This would be the first time that the modelling of antibiotics of neonates, infants and older children undergoing cardiac surgery has been attempted in this way.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11176 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 23003 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 299818 0
Government body
Name [1] 299818 0
Pathology Queensland
Address [1] 299818 0
Level 4, Block 7
Royal Brisbane and Women's Hospital
Cnr Herston and Bowen Bridge Roads
Herston Qld 4006
Country [1] 299818 0
Australia
Primary sponsor type
Other
Name
Queensland Paediatric Cardiac Services
Address
Level 7, Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 299173 0
None
Name [1] 299173 0
None
Address [1] 299173 0
NA
Country [1] 299173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300697 0
Mater Health Services North Queensland Ltd Human Research Ethics Committee [EC00412]
Ethics committee address [1] 300697 0
Mater Hospital
Level 2, Aubigny Place
Raymond Terrace
South Brisbane QLD 4101
Ethics committee country [1] 300697 0
Australia
Date submitted for ethics approval [1] 300697 0
22/11/2013
Approval date [1] 300697 0
15/04/2014
Ethics approval number [1] 300697 0
HREC/13/MHS/178

Summary
Brief summary
The objective of this study was to determine the effect of age, prolonged bypass and deep hypothermia on perioperative levels of cefazolin in children undergoing cardiac surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84514 0
A/Prof Nelson Alphonso
Address 84514 0
Level 7, Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84514 0
Australia
Phone 84514 0
+61 7 3069 5775
Fax 84514 0
Email 84514 0
nelsonalphonso@mac.com
Contact person for public queries
Name 84515 0
Mrs Jessica Suna
Address 84515 0
Queensland Paediatric Cardiac Research
Level 4, Centre for Children's Health Research
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84515 0
Australia
Phone 84515 0
+61 7 3069 7256
Fax 84515 0
Email 84515 0
jessica.suna@health.qld.gov.au
Contact person for scientific queries
Name 84516 0
A/Prof Nelson Alphonso
Address 84516 0
Level 7, Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84516 0
Australia
Phone 84516 0
+61 7 3069 5775
Fax 84516 0
Email 84516 0
nelsonalphonso@mac.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary