Cognitive changes after saline or Plasmalyte infusion in healthy volunteers: blinded, randomized cross-over trial

Phase 4

Completed

• Conditions: Cognition; Neurological - Studies of the normal brain and nervous system; Mental Health - Studies of normal psychology, cognitive function and behaviour; Hyperchloremic acidosis; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12611000124932
• Lead Sponsor: David Story

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Healthy adults not requiring any daily medication other than the contraceptive pill

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reaction Time Index<br>Previously reported test:<br>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.[Immediately before and immediately after infusions.]

Secondary Outcome Measures

Name	Time	Method
Differences in Wechsler Adult Intelligence Scale (3rd Edition) (WAIS-III): Processing Speed Index (PSI)[Immediately after infusions only.];The A/B neuropsychological assessment schedule (ABNAS): subjective cognition measure, modified to the previous hour[Immediately after infusions only.];Profile of Mood State (POMS)[Immediately after infusions only.];Clinical Chemistry: pH, standard base-excess, chloride, sodium, sodium chloride difference (Na-Cl), and measured Strong ion difference: (Na+K-Cl-Lact)[Immediately before and after infusions.]