Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001242617
Ethics application status
Approved
Date submitted
20/09/2014
Date registered
27/11/2014
Date last updated
27/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Control of hydration in hospital patients using an automated system.
Scientific title
An automated system for administering intravenous 5% dextrose to control the water balance of hospital patients, as measured by the serum sodium.
Secondary ID [1] 285375 0
None
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysnatraemias 293106 0
Condition category
Condition code
Metabolic and Endocrine 293379 293379 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. A two-compartment model of the extracellular and intracellular fluids is created using patient anthropometrics and serum laboratory results.
2. The duration of infusion will take place from admission until discharge from the unit.
3. The device has two components. A sensor attached to the urinary collection system and a central processor. These devices communicate to determine a rate of infusion.
4. To ensure adherence, the nurse caring for the patient will monitor the intravenous line as per standard clinical care.
5. The device will administer intravenous 5% dextrose at a variable dose, dependent on the need for water.
Intervention code [1] 290287 0
Treatment: Devices
Comparator / control treatment
1. Standard care, as defined by the traditional decision making process of the clinician in determining the need for water and the subsequent administration of intravenous 5% dextrose.
2. The control data was obtained for the de-identified medical records of patients in the same unit during the 12 months prior to the study. The controls are historical.
3. In the initial phase of the study no active controls will be allocated to receive standard care.
Control group
Historical

Outcomes
Primary outcome [1] 293207 0
Control of serum sodium as defined by the convergence of the serum sodium. The target rate of change of serum sodium during correction of derangements is defined as 0.5mmol/L/hour. The target sodium is 140mmol/L.
Timepoint [1] 293207 0
Serum sodium samples are taken at intervals (approximately 4-6 per day) during the length of stay in intensive care unit
Secondary outcome [1] 310596 0
Precision of control of serum sodium, as defined by a reduction in the variability of the serum sodium as compared to traditional therapy.
Timepoint [1] 310596 0
Serum sodium samples are taken at intervals (approximately 4-6 per day) during the length of stay in intensive care unit

Eligibility
Key inclusion criteria
The presence of a catheter and an intravenous cannula. The patient must be admitted to the intensive care unit to be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/12/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3005 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 289985 0
Self funded/Unfunded
Name [1] 289985 0
A/Prof William Geoffrey Parkin
Country [1] 289985 0
Australia
Primary sponsor type
Individual
Name
A/Prof William Geoffrey Parkin
Address
Intensive Care Unit, Monash Medical Centre, 246 Clayton Rd, Clayton, 3168 VIC
Country
Australia
Secondary sponsor category [1] 288670 0
None
Name [1] 288670 0
none
Address [1] 288670 0
none
Country [1] 288670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291694 0
Monash HREC
Ethics committee address [1] 291694 0
Research Directorate
Monash Medical Centre
246 Clayton Rd
Clayton
VIC
3168
Ethics committee country [1] 291694 0
Australia
Date submitted for ethics approval [1] 291694 0
Approval date [1] 291694 0
19/03/2014
Ethics approval number [1] 291694 0
13371A

Summary
Brief summary
The aim is to develop a method to safely and accurately control the water state of patients in a minimally invasive and reliable fashion. The ultimate goal is to reduce complications of inappropriate fluid administration that result in patient harm. An intermediate step is to develop a model of water balance that can inform clinicians of current water state and hence recommend appropriate rates of intravenous 5% dextrose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51578 0
A/Prof William Geoffrey Parkin
Address 51578 0
Monash Intensive Care Unit
Monash Medical Center
246 Clayton Rd
Clayton
Vic
3168
Country 51578 0
Australia
Phone 51578 0
61 3 95943616
Fax 51578 0
Email 51578 0
wgparkin@googlemail.com
Contact person for public queries
Name 51579 0
A/Prof William Geoffrey Parkin
Address 51579 0
Monash Intensive Care Unit
Monash Medical Center
246 Clayton Rd
Clayton
Vic
3168
Country 51579 0
Australia
Phone 51579 0
61 3 95943616
Fax 51579 0
Email 51579 0
wgparkin@googlemail.com
Contact person for scientific queries
Name 51580 0
A/Prof William Geoffrey Parkin
Address 51580 0
Monash Intensive Care Unit
Monash Medical Center
246 Clayton Rd
Clayton
Vic
3168
Country 51580 0
Australia
Phone 51580 0
61 3 95943616
Fax 51580 0
Email 51580 0
wgparkin@googlemail.com

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.