CompletedPhase 3ACTRN12613001370796

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

Sponsor

Medical Research Institute of New Zealand

Enrollment

2,500 participants

Start Date

Apr 1, 2014

Study Type

Interventional

Conditions

Intravenous Fluid Management in Critical Illness

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.

Eligibility

Sex: Both males and females

Inclusion Criteria1

Patients admitted to the study ICU who require crystalloid fluid therapy

Exclusion Criteria1

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

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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 resus

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.

Locations(1)

Auckland, Wellington, and Christchurch, New Zealand

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ACTRN12613001370796