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

A randomised cross-over trial to determine cognitive changes after saline versus Plasmalyte infusion in healthy volunteers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000124932
Enrollment
25
Registered
2011-02-03
Start date
2011-05-27
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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?

Interventions

0.9% saline (Baxter Healthcare, Sydney NSW), 30 ml / kg , intravenously over 1 hr. At least 24 hours washout before cross-over.

Sponsors

David Story
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026