Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000629336
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Adrenal cortical response during Extracorporeal membrane oxygenation.
Scientific title
Adrenal cortical response during Extracorporeal membrane oxygenation in children and adults admitted to Intensive Care.
Secondary ID [1] 291519 0
none
Universal Trial Number (UTN)
U1111-1196-0828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endocrine disorder due to stress from critical illness 302606 0
Condition category
Condition code
Metabolic and Endocrine 302128 302128 0 0
Other endocrine disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum-cortisol and Cortisol binding globulin will be assessed three times dialy on day 1, 2, 5, 10, 20, 30, etc. in all ages. For adult patients a Synacthen test will be performed day 3. The investigation continues till the patient is discharged from the ICU.
Intervention code [1] 297592 0
Not applicable
Comparator / control treatment
Not applicable - observational
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301562 0
Maintained diurnal Cortisol pattern during critical illness.
Timepoint [1] 301562 0
Serum-cortisol will be assessed three times daily day 1,2, 5, 10, 20, 30, etc. until ICU discharge. Samples will be taken with routine labs at 6 am, and at 4 and 11 pm.
Primary outcome [2] 301653 0
Serum cortisol bindning globulin (CBG) during critical care with ECMO support.
Timepoint [2] 301653 0
Serum-CBG will be assessed once daily on day 1,2, 5, 10, 20, 30, etc. until ICU discharge. Samples will be taken with routine labs at 6 am, and at 4 and 11 pm.
Secondary outcome [1] 333038 0
Mortality.
Timepoint [1] 333038 0
Until discharge from ICU.
Secondary outcome [2] 333467 0
Mortality.
Timepoint [2] 333467 0
Until 30 days after admittance to the ICU.
Secondary outcome [3] 333468 0
Mortality.
Timepoint [3] 333468 0
Until hospital discharge.

Eligibility
Key inclusion criteria
Consecutive patients admitted to the PICU or ECMO ICU at Karolinska University Hospital, expected to stay at least 48 hours in any of these ICU:s, and not on high-dose cortico steroids.
Minimum age
No limit
Maximum age
78 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moribund, or patients not expected to stay in the Intensive care unit for more than 48 hours, or pateints on high-dose cortico steroids.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Comparisons between chategorical data will be performed with Chi2- or Fisher's exact test. Analysis of nominal normal distributed data will be performed with t-test, while non-normal distributed data with Mann Whitney U-test. Normal distribution will be checked with Shapiro-Wilks test. A p-value less than 0.05 will be considered a significant difference.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/06/2108
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8762 0
Sweden
State/province [1] 8762 0
Stockholm

Funding & Sponsors
Funding source category [1] 296009 0
Hospital
Name [1] 296009 0
Karolinska University Hospital
Country [1] 296009 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
Eugeniavagen 23
17176 STOCKHOLM
Country
Sweden
Secondary sponsor category [1] 294895 0
University
Name [1] 294895 0
Karolinska Institutet
Address [1] 294895 0
Dept Physiology and Phamacology
Nanna Swartz vag
Karolinska Institutet
17177 SStockholm
Country [1] 294895 0
Sweden
Secondary sponsor category [2] 294896 0
University
Name [2] 294896 0
Karolinska Institutet
Address [2] 294896 0
Dept Endocrinology, Metabolism and Diabetes
Karolinska University Hospital
17176 STOCKHOLM
Country [2] 294896 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297270 0
Regional Ethical Committee in Stockholm
Ethics committee address [1] 297270 0
Nobels vag
Karolinska Institutet
17177 Stockholm
Ethics committee country [1] 297270 0
Sweden
Date submitted for ethics approval [1] 297270 0
27/02/2017
Approval date [1] 297270 0
25/04/2017
Ethics approval number [1] 297270 0
2017/450-31/1

Summary
Brief summary
This is a single center prospective observational study on adreno-cortical changes during critical illness in children and adults. The aim is to elucidate if the diurnal changes in serum cortisol is impared during critical illness in all ages, both in ECMO but also in pediatric intensive care patients. Concerining the adult population we will also perform a Synacthen test on Day 3.
Secondary aims are ICU and survival over the longer run (All cause mortality at 1, 3 and 5 years).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73530 0
Dr Lars MIKAEL Broman
Address 73530 0
ECMO Centre Karolinska
Pediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
17176 Stockholm
Country 73530 0
Sweden
Phone 73530 0
+46-70-4909474
Fax 73530 0
+46-8-51778060
Email 73530 0
[email protected]
Contact person for public queries
Name 73531 0
Dr Lars MIKAEL Broman
Address 73531 0
ECMO Centre Karolinska
Pediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
17176 Stockholm
Country 73531 0
Sweden
Phone 73531 0
+46-70-4909474
Fax 73531 0
+46-8-51778060
Email 73531 0
[email protected]
Contact person for scientific queries
Name 73532 0
Dr Lars MIKAEL Broman
Address 73532 0
ECMO Centre Karolinska
Pediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
17176 Stockholm
Country 73532 0
Sweden
Phone 73532 0
+46-70-4909474
Fax 73532 0
+46-8-51778060
Email 73532 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.