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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
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Scientific title
A randomised cross-over trial to determine cognitive changes after saline versus Plasmalyte infusion in healthy volunteers
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Secondary ID [1]
253196
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Nil
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Universal Trial Number (UTN)
U1111-1118-3129
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognition
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Hyperchloremic acidosis
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Condition category
Condition code
Neurological
258878
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0
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Studies of the normal brain and nervous system
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Metabolic and Endocrine
258949
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0
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Other metabolic disorders
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Mental Health
259236
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
257675
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Treatment: Drugs
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Comparator / control treatment
Plasmalyte (Baxter Healthcare, Sydney NSW), 30 ml / kg , intravenously over 1 hr, cross-over.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Immediately before and immediately after infusions.
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Secondary outcome [1]
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Differences in Wechsler Adult Intelligence Scale (3rd Edition) (WAIS-III): Processing Speed Index (PSI)
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Assessment method [1]
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Timepoint [1]
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Immediately after infusions only.
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Secondary outcome [2]
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The A/B neuropsychological assessment schedule (ABNAS): subjective cognition measure, modified to the previous hour
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Assessment method [2]
268607
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Timepoint [2]
268607
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Immediately after infusions only.
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Secondary outcome [3]
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Profile of Mood State (POMS)
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Assessment method [3]
268608
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Timepoint [3]
268608
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Immediately after infusions only.
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Secondary outcome [4]
268609
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Clinical Chemistry: pH, standard base-excess, chloride, sodium, sodium chloride difference (Na-Cl), and measured Strong ion difference: (Na+K-Cl-Lact)
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Assessment method [4]
268609
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Timepoint [4]
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Immediately before and after infusions.
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Eligibility
Key inclusion criteria
Healthy adults not requiring any daily medication other than the contraceptive pill
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Pharmacodynamics
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
27/05/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Dept of Anaesthesia Research Fund
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Address [1]
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Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
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Country [1]
258198
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Australia
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Primary sponsor type
Individual
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Name
David Story
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Address
Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
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Country
Australia
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Secondary sponsor category [1]
257371
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None
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Name [1]
257371
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Address [1]
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Country [1]
257371
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Other collaborator category [1]
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Individual
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Name [1]
251731
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Sarah Wilson
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Address [1]
251731
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Dept of Neuropsychology, Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
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Country [1]
251731
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Australia
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Other collaborator category [2]
251732
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Individual
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Name [2]
251732
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Laurence Weinberg
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Address [2]
251732
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Dept of Anaesthesia Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
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Country [2]
251732
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Australia
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Other collaborator category [3]
251733
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Individual
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Name [3]
251733
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Rinaldo Bellomo
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Address [3]
251733
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Dept of ICU, Austin Hospital, Studley Rd, Heidelberg,Vic, 3084
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Country [3]
251733
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260401
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
260401
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Research Ethics Unit
Austin Hospital Studley Rd Heidelberg
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Ethics committee country [1]
260401
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Australia
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Date submitted for ethics approval [1]
260401
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18/01/2010
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Approval date [1]
260401
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Ethics approval number [1]
260401
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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?
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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A/Prof David Story
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Address
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Dept of Anaesthesia
Austin Hospital
Studley Rd, Heidelberg, Vic, 3084
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Country
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Australia
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Phone
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61-3-9496 3800
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof David Story
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Address
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Dept of Anaesthesia
Austin Hospital
Studley Rd, Heidelberg, Vic, 3084
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Country
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Australia
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Phone
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61-3-9496 3800
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Fax
6136
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Cognitive Changes after Saline or Plasmalyte Infusion in Healthy Volunteers
2013
https://doi.org/10.1097/aln.0b013e31829416ba
N.B. These documents automatically identified may not have been verified by the study sponsor.
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