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Trial registered on ANZCTR


Registration number
ACTRN12611000124932
Ethics application status
Approved
Date submitted
2/02/2011
Date registered
3/02/2011
Date last updated
18/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive changes after saline or Plasmalyte infusion in healthy volunteers: blinded, randomized cross-over trial
Scientific title
A randomised cross-over trial to determine cognitive changes after saline versus Plasmalyte infusion in healthy volunteers
Secondary ID [1] 253196 0
Nil
Universal Trial Number (UTN)
U1111-1118-3129
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 258725 0
Hyperchloremic acidosis 258800 0
Condition category
Condition code
Neurological 258878 258878 0 0
Studies of the normal brain and nervous system
Metabolic and Endocrine 258949 258949 0 0
Other metabolic disorders
Mental Health 259236 259236 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.9% saline (Baxter Healthcare, Sydney NSW), 30 ml / kg , intravenously over 1 hr. At least 24 hours washout before cross-over.
Intervention code [1] 257675 0
Treatment: Drugs
Comparator / control treatment
Plasmalyte (Baxter Healthcare, Sydney NSW), 30 ml / kg , intravenously over 1 hr, cross-over.
Control group
Active

Outcomes
Primary outcome [1] 259807 0
Reaction Time Index
Previously reported test:
VELISSARIS, S. L., WILSON, S. J., NEWTON, M. R., BERKOVIC, S. F. & SALING, M. M. (2009) Cognitive complaints after a first seizure in adulthood: Influence of psychological adjustment. Epilepsia, 50, 1012-21.
Timepoint [1] 259807 0
Immediately before and immediately after infusions.
Secondary outcome [1] 268606 0
Differences in Wechsler Adult Intelligence Scale (3rd Edition) (WAIS-III): Processing Speed Index (PSI)
Timepoint [1] 268606 0
Immediately after infusions only.
Secondary outcome [2] 268607 0
The A/B neuropsychological assessment schedule (ABNAS): subjective cognition measure, modified to the previous hour
Timepoint [2] 268607 0
Immediately after infusions only.
Secondary outcome [3] 268608 0
Profile of Mood State (POMS)
Timepoint [3] 268608 0
Immediately after infusions only.
Secondary outcome [4] 268609 0
Clinical Chemistry: pH, standard base-excess, chloride, sodium, sodium chloride difference (Na-Cl), and measured Strong ion difference: (Na+K-Cl-Lact)
Timepoint [4] 268609 0
Immediately before and after infusions.

Eligibility
Key inclusion criteria
Healthy adults not requiring any daily medication other than the contraceptive pill
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Decline to participate.
2. Pregnant women
3. Aged less than 18 years.
4. Aged more than 60 years
5. Require any daily medication other than the contraceptive pill.
6. Heart disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
25 particpants invited to volunteer for randomized cross-over trial. Alocation to first arm of cross over in opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Table of random numbers of 0 and 1 for first infusion of cross-over
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258198 0
Hospital
Name [1] 258198 0
Dept of Anaesthesia Research Fund
Address [1] 258198 0
Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
Country [1] 258198 0
Australia
Primary sponsor type
Individual
Name
David Story
Address
Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
Country
Australia
Secondary sponsor category [1] 257371 0
None
Name [1] 257371 0
Address [1] 257371 0
Country [1] 257371 0
Other collaborator category [1] 251731 0
Individual
Name [1] 251731 0
Sarah Wilson
Address [1] 251731 0
Dept of Neuropsychology, Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
Country [1] 251731 0
Australia
Other collaborator category [2] 251732 0
Individual
Name [2] 251732 0
Laurence Weinberg
Address [2] 251732 0
Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
Country [2] 251732 0
Australia
Other collaborator category [3] 251733 0
Individual
Name [3] 251733 0
Rinaldo Bellomo
Address [3] 251733 0
Dept of ICU, Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
Country [3] 251733 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260401 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 260401 0
Research Ethics Unit
Austin Hospital Studley Rd Heidelberg
Ethics committee country [1] 260401 0
Australia
Date submitted for ethics approval [1] 260401 0
18/01/2010
Approval date [1] 260401 0
Ethics approval number [1] 260401 0

Summary
Brief summary
Intravenous crytsalloid fluids are one of the mainstays of in-hospital patient treatment with fluid intervention
being ubiquitous for surgical and critical care patients. Cognitive changes such as a perceived difficulty in
abstract thinking or mental arithmetic has been reported in subjects exposed to a commonly prescribed
crystalloid solution - Normal Saline (0.9%). The postulated mechanism for the altered cognition is unclear
but could be a result of NS 0.9% induced hyperchloraemia or NS 0.9% induced acidaemia (normal anion
gap metabolic acidosis) that frequently occurs following saline administration. No study has attempted to
formally investigate cognitive changes after the administration of saline or other commonly administered
crystalloid solutions. Plasmalyte solution is a frequently used crystalloid solution with similiar properties to
saline. However it is a more physiological and balanced crystalloid solution compared to saline as it has a
significantly lower chloride concentration and physiochemical profile similar to normal plasma.
Study hypothesis: Is normal saline associated with greater cognitive changes than Plasmalyte in healthy
volunteers?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31961 0
Address 31961 0
Country 31961 0
Phone 31961 0
Fax 31961 0
Email 31961 0
Contact person for public queries
Name 15208 0
A/Prof David Story
Address 15208 0
Dept of Anaesthesia
Austin Hospital
Studley Rd, Heidelberg, Vic, 3084
Country 15208 0
Australia
Phone 15208 0
61-3-9496 3800
Fax 15208 0
Email 15208 0
David.Story@austin.org.au
Contact person for scientific queries
Name 6136 0
A/Prof David Story
Address 6136 0
Dept of Anaesthesia
Austin Hospital
Studley Rd, Heidelberg, Vic, 3084
Country 6136 0
Australia
Phone 6136 0
61-3-9496 3800
Fax 6136 0
Email 6136 0
David.Story@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary