Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000072415
Ethics application status
Approved
Date submitted
23/06/2006
Date registered
23/01/2007
Date last updated
23/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Endocrine function following Heart Surgery in Infants less than 3 months of age.
Scientific title
Thyroid hormone levels and cortisol levels post congenital heart surgery in infants less than 3 months of age. Delineation of acceptable range and investigation of association with outcome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid & Adrenal dysfunction following congenital heart surgery in infants less than 3 months of age 1564 0
Condition category
Condition code
Metabolic and Endocrine 1665 1665 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Thyroid and adrenal hormone concentrations decrease following congenital heart surgery, in older children this usually returns to normal after 1 week. This study will establish how quickly adrenal and thyroid hormone concentrations return to normal in infants less than 3 months of age following congential heart surgery, and whether there is any association between the amount of decrease or a delayed in adrenal / thyroid recovery and worse outcome.
Nil intervention except short synacthen test for assessment of adrenal reserve.
Intervention code [1] 1159 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2305 0
Hospital mortality
Timepoint [1] 2305 0
Up to 3 months
Secondary outcome [1] 4015 0
Length of ventilation
Timepoint [1] 4015 0
Secondary outcome [2] 4016 0
Paediatric Intensive Care Unit length of stay
Timepoint [2] 4016 0
Secondary outcome [3] 4017 0
Inotrope score
Timepoint [3] 4017 0
Daily
Secondary outcome [4] 4018 0
Pediatric Logistic Organ Dysfunction score
Timepoint [4] 4018 0
Daily

Eligibility
Key inclusion criteria
Post cardiac surgery.
Minimum age
Not stated
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known thyroid or adrenal disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 359 0
New Zealand
State/province [1] 359 0

Funding & Sponsors
Funding source category [1] 1810 0
Charities/Societies/Foundations
Name [1] 1810 0
Greenlane Research and Education Fund
Country [1] 1810 0
New Zealand
Primary sponsor type
Individual
Name
Principle Investigator - Kevin Plumpton
Address
Country
Secondary sponsor category [1] 1632 0
Hospital
Name [1] 1632 0
Starship Paediatric Intensive Care Unit
Address [1] 1632 0
Country [1] 1632 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3395 0
Starship Children's Hospital-Northern Y regional Ethics Committee
Ethics committee address [1] 3395 0
Ethics committee country [1] 3395 0
New Zealand
Date submitted for ethics approval [1] 3395 0
Approval date [1] 3395 0
20/06/2006
Ethics approval number [1] 3395 0
NTY/06/05/038

Summary
Brief summary
This observational study aims to further the understanding of how the endocrine system recovers following congenital heart surgery. Infants less than 3 months of age have more deaths and complications following congenital heart surgery than older children and adults. They have immature organ systems and may not be able to respond as rapidly as older children to the critical illness that congenital heart surgery causes. The study requires extra blood samples to be taken in addition to the routine blood tests that are taken during the recovery period in the paediatric intensive care unit. These blood samples will be obtained from indwelling lines that the patients will have in place. The test results will be analysed to delineate what an acceptable range for thyroid and adrenal hormones is in this age group following congenital heart surgery, to assess the association of low hormone levels and poor outcome measures, and to identify a group of patients for enrolment in future studies of hormone replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35790 0
Address 35790 0
Country 35790 0
Phone 35790 0
Fax 35790 0
Email 35790 0
Contact person for public queries
Name 10348 0
Kevin Plumpton
Address 10348 0
Paediatric Intensive Care Unit (PICU)
Level 2
Starship Children’s Hospital
Private Bay 92024
Auckland
Country 10348 0
New Zealand
Phone 10348 0
+64 9 3074903
Fax 10348 0
Email 10348 0
[email protected]
Contact person for scientific queries
Name 1276 0
Kevin Plumpton
Address 1276 0
Paediatric Intensive Care Unit (PICU)
Level 2
Starship Children’s Hospital
Private Bay 92024
Auckland
Country 1276 0
New Zealand
Phone 1276 0
+64 9 3074903
Fax 1276 0
Email 1276 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.