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0.9% saline vs. Plasma-Lyte 148 for Intensive Care Fluid Therapy. (the SPLIT study)

A multi-centre, cluster randomised, double cross over, feasibility trial investigating the effect of using 0.9% saline or Plasma-lyte 148 as fluid therapy on the risk of developing acute kidney injury in intensive care patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001370796
Acronym
The SPLIT study
Enrollment
2262
Registered
2013-12-13
Start date
2014-04-01
Completion date
2014-10-14
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

The administration of intravenous fluid is a common therapy in acutely unwell patients. The study will provide preliminary data from a large interventional trial to inform clinicians looking after acutely unwell patients as to whether 0.9% saline or Plasma-Lyte 148 'Registered Trademark' is the preferred fluid for routine use in the ICU.

Interventions

0.9% saline for intravenous fluid therapy in intensive care. The rate, duration, and frequency of fluid administration will determined by the treated clinician. All fluid used for either fluid resuscitation or crystalloid rehydration will be 0.9% saline unless a specific indication exists for another fluid. Each of the four study ICUs will be randomly assigned, in alternating seven week blocks, to use blinded 0.9% saline or Plasma-Lyte 148 as the default resuscitation fluid. There will be no

0.9% saline for intravenous fluid therapy in intensive care. The rate, duration, and frequency of fluid administration will determined by the treated clinician. All fluid used for either fluid resuscitation or crystalloid rehydration will be 0.9% saline unless a specific indication exists for another fluid. Each of the four study ICUs will be randomly assigned, in alternating seven week blocks, to use blinded 0.9% saline or Plasma-Lyte 148 as the default resuscitation fluid. There will be no wash-out period between treatments. Each patient will receive the treatment they were assigned at the time of their ICU admission for the entire duration of their ICU admision irrespective of whether a cross-over occurs while they are admitted.

Sponsors

Medical Research Institute of New Zealand
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Patients admitted to the study ICU who require crystalloid fluid therapy

Exclusion criteria

1. patients currently receiving or expected to require renal replacement therapy within six hours of ICU admission 2. patients who are usually on dialysis for end stage renal failure 3. patients who are admitted to the ICU solely for consideration of organ donation or for palliative care 4. patients previously enrolled in the SPLIT study

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026