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Trial registered on ANZCTR


Registration number
ACTRN12614001178639
Ethics application status
Not yet submitted
Date submitted
28/10/2014
Date registered
10/11/2014
Date last updated
30/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Routine Use Of 0.9% Saline Vs. Routine Use Of Plasma-Lyte 148 (Registered Trademark) For Intravenous Fluid Therapy In Emergency Department Patients
Scientific title
Routine Use Of 0.9% Saline Vs. Routine Use Of Plasma-Lyte 148 'Registered Trademark' For Intravenous Fluid Therapy In Emergency Department Patients: a comparison of kidney function, hospital length of stay, intensive care admission and mortality.
Secondary ID [1] 285551 0
Nil
Universal Trial Number (UTN)
U1111-1155-0632
Trial acronym
SPLITED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous Fluid Management in Emergency Department Patients 293370 0
Condition category
Condition code
Cardiovascular 293652 293652 0 0
Other cardiovascular diseases
Anaesthesiology 293653 293653 0 0
Other anaesthesiology
Renal and Urogenital 293654 293654 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single centre, open label, before and after audit.

One month prior to the intervention period there will be Emergency Department (ED) staff education and logistic arrangements for changing to Plasma-Lyte 148 'Registered Trademark' as the default IV fluid. During the 12 week intervention period Plasma-Lyte 148 'Registered Trademark' will be used as the default primary crystalloid fluid. The dosing regimen is at the discretion of the treating clinician.

A random sample of 100 patients that received fluid in emeregency department will be assessed to see extact type and amount of given.
Intervention code [1] 290496 0
Treatment: Other
Comparator / control treatment
Data will be retrospectively collected for a 12 week control period exactly one year prior to the intervention period to allow for minimisation of seasonal effects. During the control period the predominant intravenous fluid prescribed in Wellington Hospital was 0.9 % saline
Control group
Historical

Outcomes
Primary outcome [1] 293466 0
The primary outcome measure is the delta creatinine (the difference between admission and peak serum creatinine in the first seven days in hospital).
Timepoint [1] 293466 0
The baseline creatinine will be the creatinine measured at ED presentation. The peak creatinine will be the highest creatinine in the first seven days in hospital.

In the event that the creatinine is not measured again after hospital admission the delta creatinine will be defined as zero.
Secondary outcome [1] 311104 0
The proportion of patients with acute kidney injury or failure based on creatinine levels in accordance with RIFLE-criteria during the first seven days in hospital
Timepoint [1] 311104 0
based on the highest value measured during the first seven days in hospital.
Secondary outcome [2] 311105 0
The proportion of patients with acute kidney injury or failure based on creatinine levels in accordance with KDIGO stage during the first seven days in hospital.
Timepoint [2] 311105 0
based on the highest value measured during the first seven days in hospital.
Secondary outcome [3] 311106 0
Composite outcome of the proportion of patients:
- requiring renal replacement therapy
- in-hospital death
- need for ICU admission
Timepoint [3] 311106 0
As collected from computerized central hospital databases from from date of ED presentation until hospital discharge or death.
Secondary outcome [4] 311107 0
Duration of ICU admission
Timepoint [4] 311107 0
At discharge from ICU
Secondary outcome [5] 311108 0
Duration of Hospital stay
Timepoint [5] 311108 0
At discharge from hospital

Eligibility
Key inclusion criteria
Patients >18 year presenting to ED and subsequently admitted to hospital who have a serum creatinine measured in the ED
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on renal replacement therapy for end stage renal failure.

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)
This audit will use be an open label, before-and-after design.

The audit will be conducted with two 12 week periods occurring during the same time of the year to minimise seasonal effects.

Data for the control period will be retrospectively taken for a 12 week period exactly one year prior to start date for intervention period. During this control period patients admitted to Wellington Regional Hospital from ED would have received intravenous (IV) fluid at the discretion of the treating clinician, in which 0.9% saline would have been used as the preferred primary crystalloid fluid therapy.

Prior to the commencement of the 12 week intervention period there will be a 4 week period of staff education and logistic arrangements for fluid switching from 0.9 % saline to Plasma-Lyte148 'Registered Trademark'. During the 12 week intervention period patients in ED will receive Plasma-Lyte148 'Registered Trademark' as the preferred primary crystalloid fluid.

Both 0.9% saline and Plasma-Lyte 148 'Registered Trademark' will be available in the situations, where, in the opinion of the treating ED specialist, there is a clinical indication for one fluid or the other. Specific fluids will be available for use in rare situations where the treating clinician believes that there is an indication for one fluid or the other.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This project is an audit of practice change and is therefore exempt from requirements for informed consent. The audit involves no departure from standard care and does not involve the collection of any data that are not already being collected for clinical and / or quality assurance purposes. In this audit, whether or not ED patients receive 0.9% saline or Plasma Lyte 'Registered Trademark' 148 as default therapy will be determined by the timing of the introduction of change in therapy.

This Audit has been prospectively registered and approved as a clinical audit by the Coast District Health Board Audit Commitee.

Data will be collected from computerised central hospital and laboratory databases at the completion of the audit. All baseline and outcome data (expect creatinine) is routinely collected and coded as part of the National Minimum Dataset (NMDS). The creatinine on admission and daily creatinine we will be collected from the central laboratory database.

Details of the volume and type of fluid actually received by each patient will not be collected. However, a random sample of 100 patients in each treatment period who received intravenous fluid in ED and were admitted to hospital will be reviewed to assess the volume and type of fluid administered in ED. The number of patient records reviewed to obtain 100 patients who received IV fluids will be reported
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
No large-scale interventional trial has compared the use of 0.9% saline to a buffered crystalloid solution. As such, the principal reasons for conducting this program of studies will be to determine feasibility and inform future sample size calculations. All studies are set to run for a specific period of time and have no fixed recruitment number.

All continuous variables will be assessed for normality and log-transformed where appropriate. Baseline comparisons between groups will be determined using chi-square tests for equal proportion (or Fishers exact tests for small numbers), student t-tests for normally distributed variables and Wilcoxon ranks sum tests otherwise.
Binomial outcomes will be analysed using poisson regression models with results reported as Relative Risks (95%CI). Continuous outcomes will be analysed using mixed linear modelling with results reported as differences (95%CI) or ratios (95%CI) as appropriate.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment outside Australia
Country [1] 6439 0
New Zealand
State/province [1] 6439 0

Funding & Sponsors
Funding source category [1] 290154 0
Commercial sector/Industry
Name [1] 290154 0
Baxter Healthcare
Country [1] 290154 0
Australia
Funding source category [2] 290155 0
Charities/Societies/Foundations
Name [2] 290155 0
Medical Research Institute of New Zealand
Country [2] 290155 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Private Bag 7901, Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 288864 0
None
Name [1] 288864 0
Address [1] 288864 0
Country [1] 288864 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291906 0
See Public Notes section
Ethics committee address [1] 291906 0
N/a
Ethics committee country [1] 291906 0
Date submitted for ethics approval [1] 291906 0
06/11/2014
Approval date [1] 291906 0
Ethics approval number [1] 291906 0

Summary
Brief summary
This will be an audit to provide preliminary data to address whether the use of Plasma-Lyte148 'Registered Trademark' as default intravenous fluid results in better clinical outcomes compared to current standard practice.

The audit will be conducted with two 12 week periods. During the control period patients admitted to Wellington Regional Hospital from ED would have received intravenous fluid at the discretion of the treating doctors, in which 0.9% saline would have been the preferred intravenous fluid. This will be compared a 12 weeks where the preferred fluid will be Plasma-Lyte148 'Registered Trademark'.

The outcomes that will be recorded will be kidney function, hospital length of stay, intensive care admission and mortality.
Trial website
Trial related presentations / publications
Public notes
This study will be an audit looking at before and after a practice change. As such does not require NZ HDEC ethical approval.
However this audit has been approved and registered as a clinical audit by Capital and Coast District Health Board.

Contacts
Principal investigator
Name 52330 0
Dr Sumeet Reddy
Address 52330 0
Medical Research Institute of New Zealand
Private Bag 7901, Wellington 6242
Country 52330 0
New Zealand
Phone 52330 0
+64 4 805 0239
Fax 52330 0
Email 52330 0
[email protected]
Contact person for public queries
Name 52331 0
Sumeet Reddy
Address 52331 0
Medical Research Institute of New Zealand
Private Bag 7901, Wellington 6242
Country 52331 0
New Zealand
Phone 52331 0
+64 4 805 0239
Fax 52331 0
Email 52331 0
[email protected]
Contact person for scientific queries
Name 52332 0
Sumeet Reddy
Address 52332 0
Medical Research Institute of New Zealand
Private Bag 7901, Wellington 6242
Country 52332 0
New Zealand
Phone 52332 0
+64 4 805 0239
Fax 52332 0
Email 52332 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.