Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12612000046808
Ethics application status
Approved
Date submitted
6/01/2012
Date registered
10/01/2012
Date last updated
21/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, multi-centre observational study in patients admitted to intensive care to estimate daily sodium balance
Scientific title
A prospective, multi-centre observational study in patients admitted to intensive care to estimate daily sodium balance
Secondary ID [1] 279672 0
Nil
Universal Trial Number (UTN)
U1111-1126-8648
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Daily sodium balance 285493 0
Condition category
Condition code
Metabolic and Endocrine 285715 285715 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Daily Sodium balance for 48 hours after inclusion: It Involves daily estimation of administered sodium from all the sources including fluids, feeds and infusions (from the bed side charts) and estimated daily sodium balance by measuring 24 hour urine sodium.
Duration : 18 months
Intervention code [1] 283962 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286219 0
Daily sodium balance: It Involves daily estimation of administered sodium from all the sources including fluids, feeds and infusions (from bedside charts) and estimated daily sodium balance by measuring 24 hour urine sodium.
Timepoint [1] 286219 0
up to 48 hours after randomization
Secondary outcome [1] 295403 0
Length of invasive mechanical ventilation (using medical record data)
Timepoint [1] 295403 0
28 days
Secondary outcome [2] 295404 0
ICU and hospital length of stay ( (using medical record data)
Timepoint [2] 295404 0
28 days
Secondary outcome [3] 295405 0
ICU, hospital and 28-day mortality (using medical record data)
Timepoint [3] 295405 0
28 days

Eligibility
Key inclusion criteria
age greater than or equal to 18 years;
invasive mechanical ventilation initiated within the previous 48 hours and expected to require mechanical ventilation for a further 48 hours;
in-dwelling urinary catheter in situ
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
: 1) age <18 years; 2) planned or potential requirement for renal replacement therapy in the next 48 hours; 3) traumatic brain injury (current admission diagnosis); 4) diabetic ketoacidosis or hyperglycaemic hyperosmolar syndrome (current admission diagnosis); 5) surgical patients (post- operative); 6) expected death within the next 24 hours; 7) suspected or confirmed pregnancy and ; 8) documented past history of chronic liver disease

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2012
Actual
4/04/2012
Date of last participant enrolment
Anticipated
Actual
20/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4846 0
5011
Recruitment postcode(s) [2] 4847 0
2050
Recruitment postcode(s) [3] 4848 0
5042

Funding & Sponsors
Funding source category [1] 284457 0
Self funded/Unfunded
Name [1] 284457 0
Country [1] 284457 0
Primary sponsor type
Individual
Name
Shailesh Bihari
Address
Department of Intensive Care Unit
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 283384 0
Individual
Name [1] 283384 0
Sandra Peake
Address [1] 283384 0
The Queen Elizabeth Hospital
Department of Intensive Care Medicine
1st Floor Main Building
28 Woodville Road, Woodville. S.A. 5011
Country [1] 283384 0
Australia
Secondary sponsor category [2] 283385 0
Individual
Name [2] 283385 0
Andrew D Bersten
Address [2] 283385 0
Department of Intensive Care Unit
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Country [2] 283385 0
Australia
Other collaborator category [1] 260424 0
Individual
Name [1] 260424 0
Manoj Saxena
Address [1] 260424 0
Critical Care & Trauma Division

The George Institute for Global Health
Level 7, 341 George St. Sydney NSW 2000
Country [1] 260424 0
Australia
Other collaborator category [2] 260425 0
Individual
Name [2] 260425 0
Peter Garrett
Address [2] 260425 0
Intensive Care Unit
Nambour General Hospital
PO Box 547
Nambour QLD 4560
Country [2] 260425 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286434 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286434 0
Ethics committee country [1] 286434 0
Australia
Date submitted for ethics approval [1] 286434 0
12/10/2011
Approval date [1] 286434 0
16/12/2011
Ethics approval number [1] 286434 0
1/11/0420

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33586 0
Dr Shailesh Bihari
Address 33586 0
Dept of ICU, Flinders Medical Centre, Flinders Drive, Bedford Park. South Australia 5042
Country 33586 0
Australia
Phone 33586 0
61 8 82047288
Fax 33586 0
+61 8 82045751
Email 33586 0
[email protected]
Contact person for public queries
Name 16833 0
Shailesh Bihari
Address 16833 0
Department of ICU
Flinders medical centre
Flinders Drive
Bedford Park SA 5042
Australia
Country 16833 0
Australia
Phone 16833 0
+61 8 82044247
Fax 16833 0
+61 8 82045751
Email 16833 0
[email protected]
Contact person for scientific queries
Name 7761 0
Shailesh Bihari
Address 7761 0
Department of ICU
Flinders medical centre
Flinders Drive
Bedford Park SA 5042
Australia
Country 7761 0
Australia
Phone 7761 0
+61 8 82044247
Fax 7761 0
+61 8 82045751
Email 7761 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.